Expert Details

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert ID: 736123 Indiana, USA

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Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 12 years of industrial experience as a medical device, biologic, pharmaceutical, food, and tobacco products industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. As such, Expert is familiar with all types of FDA and internationally regulated products and operations.

His educational background includes two BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame, an MBA in International Business from Indiana University, and a MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices with a concentration in Regulatory Compliance from Northeastern University. Currently, Expert is pursuing a Ph.D. in Business Administration with a concentration in International Business from South University. As such, not only does Expert have vast internal working knowledge of FDA operations, but he also understands the need to balance industry business goals against external regulations, the linkages between the various quality system and clinical subsystems, and the struggles with quality, cultural, and business barriers to achieve sound quality systems.

Expert has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, combination product, and clinical facilities, but has also performed various quality assurance and regulatory compliance operations for various FDA and international governmental bodies’ regulated industries, such as monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, reconciling and analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, and informing management and staff of current FDA and international enforcement policies.

His expertise is primarily in medical device and combination product quality assurance and regulatory compliance, and has vast knowledge utilizing U.S., European Union, Canadian, Australian, Brazilian, Japanese, Chinese, and other international medical device and combination product quality system, regulatory, legal, and clinical laws, regulations, standards, and guidelines. However, he is also familiar with and knows the similarities and differences between US food, human and animal pharmaceutical, cosmetic, biologic, tissue, clinical, and tobacco product laws, regulations, guidelines, and operations as well.

Expert is a self-starter with good written and oral communications skills and has a strong history and a proven and successful track record of accomplishment through leading and/or working with teams. Expert strives for continuous improvement, consistency in quality assurance and regulatory compliance with reduced waste while auditing, consulting, and contracting medical device, biologic, and pharmaceutical facilities. Expert has participated in multiple projects to problem solve and has participated in and/or set up quality audit teams and wrote team reports while in the governmental and industrial capacities. In all projects, Expert has demonstrated hands on expertise in various regulatory compliance and quality assurance activities. As such, these expert skills and knowledge have resulted in increased quality, regulatory, legal, business, and operating integrity for not only the management and staff Expert has assisted, but also for the greater protection of the U.S. and international consumers as well.

In addition, Expert is not the typical regulatory compliance and quality assurance expert. Not only does Expert understand the inner workings of the FDA and regulated industries and staff, but also understands international business and management operations too. Expert’s Myers-Briggs profile is also non-typical as well (i.e. an ‘off-the-chart’ ENFP profile, which is in the direct opposition to many quality and regulatory personnel). Unlike many people, Expert excels in public speaking and mentoring/ coaching others to succeed. Also, due to his strong “highly moral and ethical” beliefs, Expert is not afraid to challenge and educate unethical and immoral personnel so that they may understand the legal and regulatory consequences of their questionable and biased actions. These additional strengths have given Expert the necessary skills to multi-task, work as a team player, and be a leader, coach, and mentor while understanding the mechanisms of quality systems and the subsystem linkages balanced with the internal and external business constraints of clients. Therefore, for over 34 years, Expert has successfully assisted numerous US and foreign companies to achieve quality and regulatory compliance, especially in the medical device and combination product arenas.

ASQ certified (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems. Expert's career has been concentrating on US/ EU/ Canadian/ Australian/ Brazilian/ Japanese/ Chinese medical device auditing, investigating, compliance, and regulatory (except for preparing regulatory submissions). He is not a quality engineer or a regulatory affairs specialist; nor has he set up process validations, design and process specifications, nor have written any regulatory submissions (i.e. 510(k)'s, PMA's, technical files, or design dossiers). However, he is familiar with quality engineering and regulatory affairs operations, processes, and activities and has successfully performed process validations in accordance to validation protocols, inspected, tested, and measured products in accordance to master record specifications, assisted SMEs with 510(k) reviews and replies, and audited and reviewed thousands of written procedures, quality records, quality system records, regulatory submissions, process validations, and design studies to see if they conform to external laws, directives, regulations, standards, and guidance. Expert has seen all types of quality system and clinical operations, conducted gap analyses/ data reconciliations, and has given training and guidance to both governmental and industry personnel in these and other pharmaceutical, biologic, and medical device areas for over 34 years. He has also performed various hands-on non-technical quality assurance and regulatory compliance operations, such as preparing/ revising written procedures, preparing 21 CFR 803 baseline reports, conducting out of specification investigations, performing data reconciliations, and monitoring and maintaining complaints, non-conformances and CAPA's. Expert is willing to take assignments anywhere worldwide and travel 100% (including internationally).

34 years of professional experience as a level II certified international medical device investigator in the US government or as a contract quality assurance consultant and regulatory compliance specialist in the medical device industry, Expert has a strong history and a proven track record of leading or working with the team in quality auditing of domestic and international class I/III medical device products, facilities and operations. He strives for continuous improvement, and consistent quality assurance with reduced waste while auditing, consulting, and contracting medical device facilities. This includes auditing, reviewing, and critiquing all validation/ verification, protocol documentation, set up testing, build fixtures, define and setup quality assurance programs, and train personal (in-house, and/or contractors, local and offshore) while insuring a quality FDA QSR and/or ISO 9000-9003 certified build. Expert has participated in multiple projects to problem solve while working in the government arena and as a medical device consultant. He has participated in and/or set up quality audit teams and wrote team reports while in the government or as a consultant; audited, reviewed, and critiqued FMEA's, data and ongoing design considerations. In all audit and consulting projects, he has demonstrated hands on expertise. These skills have resulted in increased quality and operating integrity.

HIGHLIGHTS OF QUALIFICATIONS
• Medical Device Compliance
• Results Oriented
• Problem Resolution
• Failure Modes & Effects Analysis
• Strong Negotiation Skills
• Strategic Planning
• Excellent Communication Skills
• Team Player and Leader
• Project Management

SELECTED ACHIEVEMENTS
Quality Assurance Consultant, Regulatory Compliance Specialist, ASQ certified Quality Biomedical Auditor (QBA), and FSPCA certified Preventive Controls Qualified Individuals (PCQI) (for past 12+ years, since 2006) for various food, tobacco product, biologic, pharmaceutical, and medical device manufacturers (including combination product manufacturers), including:
• Conducts first party (internal), second party (supplier), and 3rd party (mock, specialized, trace-back, and process) audits, investigations, and gap analyses of quality system and regulatory operations using FDA and various international laws, regulations, directives, standards, and guidance, including 21 CFR 3 & 4 (combination product), 21 CFR 11 (electronic records and signatures), 21 CFR 50-58 & 812-814 (BIMO), 21 CFR 110 (food GMP), 21 CFR 210/211 (drug cGMP), 21 CFR 604 (biologic GMP), 21 CFR 803 (MDR), 21 CFR 806 (CAR), 21 CFR 807 (registration and listing), 21 CFR 809 (IVD), 21 CFR 820 (QSR), 21 CFR 821 (Tracking), EU Active Implant Device Directive (AIDD, EU In-Vitro Diagnostic Directive (IVDD), EU Medical Devices Directive (MDD), EU Medical Device Regulation (MDR), Canadian SOR.98-282, Japanese JQMS MHLW Ordinance #169, Brazilian Resolution No 59, Chinese SFDA GMP for Medical Device #833, and Australian Therapeutic Goods (Medical Devices) Regulations # 236, and various US and international standards and guidance documents, including ISO 13485 & ISO 14971, EU’s MEDDEV 2.12-1, and FDA’s IOM, QSIT, RPM, and compliance programs (such C/Ps 7348.808, 7348.811, 7383.001, and 7382.845).
• Provides regulatory, quality, and technical expertise to top management.
• Directs mock/internal/external FDA QSR, product, and process audits and investigations of manufacturing facilities, including corporate audits of subsidiaries and divisions, within the medical device, pharmaceutical, biologics, and tissue realms.
• Performs gap analysis and initial qualification of GLP facilities for USA Sponsor-Monitor of investigation device exemption (IDE) medical device using FDA laws and regulations.
• Facilitates training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/research and development (R&D), and production departments.
• Analyzes business, legal, quality, sterilization, and nonconformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.
• Performs various reconciliation activities, including corrective action planning, procedural reviews, auditing, procedural revisions, and training.
• Serves as resource for customized marketing research in industries or areas related to FDA medical device quality systems, governmental registration process, international business, and QSR/cGMP.
• Performs and/or assists in FDA Warning Letter and Consent Decree reconciliations, including food sanitation, drug cGMP, and medical device quality system (such as design control, change management, and CAPA system) corrections.
• Provides expert quality and regulatory expertise to various industry and legal personnel pertaining to adulterated/ misbranded/ non-conforming medical devices and non-compliant quality systems.
• Performs and/or assists in various front-room and back room inspection readiness activities prior to, during, and after FDA medical device inspections at U.S. and foreign medical device facilities.
• Acts as an FDA medical device quality assurance and regulatory compliance expert in various legal cases.
• Oversees, monitors, and maintains product and quality system failure investigations, nonconformances, complaints/medical device reports, and Corrective Action/Preventive Action (CAPA) programs.
• Reconciles and analyzes numerous quality system procedures and data.
• Writes and revises top- and mid-level written procedures.
• Trains various governmental and industry personnel in various areas of medical device quality, quality system, quality auditing, design control, CAPA system, and documentation and change control.
• Has internal working of FDA field and headquarter offices (including ORA and CDRH).
• Performs process validation activities in accordance to approved process validation protocols.
• Performs inspection, testing, and measurement activities on received, in-process, and finished products in accordance to approved master records and quality system requirements.

Analyst/ Level II certified International Medical Device Investigator for the FDA (for 21+ years up to 2006), including:
• Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry.
• Performed full foreign medical device inspections for over 10 years at sites manufacturing all classes and types of medical devices located throughout Asia, Canada, and Europe.
• Advised industry, state, and local officials and consumers on enforcement policies.
• Led training sessions on inspection and investigation techniques and other related topics.
• Served as subject matter expert on all provisions of the Federal Food, Drug, and Cosmetic Act.
• Conducted all types of independent inspections and investigations with minor or no supervisory guidance. The knowledge and experience to conduct all types of inspections and investigations meeting FDA requirements. These inspections included complex, unusual and intricate manufacturing processes, dealing with uncooperative firm managers and personnel. Successfully collaborated with other agencies including local, state, and federal to meet FDA guidelines.
• Collaborated and managed all types of medical device inspections and investigations, including inspections conducted the FDA. Participated in the Agency’s Foreign Inspection Program, concentrating in the medical device area.
• Managed food sanitation, drug, cosmetic and medical device inspections and various investigations including complaint follow-ups, recall audit checks, and undercover buys. Responsible for independently conducting all import operations at this resident post with no supervisory guidance.
• Trained various local, state and federal investigators in food sanitation, medical device, biologic and drug inspection techniques and in import operations. Worked independently and have become familiar computer operations. Involved in classroom and OJT training of peers and lower level district employees in the medical device area. Mentored lower level employees in the medical device area.
• Recommended to regional and district management officials as to whether or not a firm / individual involved in the production, control, and testing of medical devices and diagnostic products complies regarding Current Good Manufacturing Practices (CGMP). Analyzed reports of inspections and investigations for violations and determine the sufficiency of evidence.
• Managed the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety data. Coordinated the collection of data, managed a scientific review, and recommended a course of action, such as product guideline performance test standards and product recalls.
• Developed and implemented formal training programs for Agency personnel and provided technical expertise to industry representatives. Conducted on-the job training for Consumer Safety Officers and others and other training for investigators, supervisors, compliance officers, district personnel, and industry regarding technical and scientific matters, inspection / investigation issues, policies, and laws affecting the medical device program.

SKILLS
• Audit, review, and critique most lean related quality system, manufacturing, testing, and design technologies.
• Perform regulatory compliance data reconciliations and documentation and change control and FDA classification, registration, and listing operations.
• Skilled in quality and business concepts, including quality systems and international business management.
• Revise, prepare, audit, review and critique QA (quality assurance) and QC (quality control) programs and documentation to ensure quality production.
• Provide QA/ QC, manufacturing. and test support for manufacturing, floor, and contract vendor production lines.
• Provide information and support for ongoing product design and new product design review boards.
• Audit, review and critique all quality system procedures, records, protocols, reports, and other quality and regulatory documentation [including QMs (quality manuals), SOPs (Standard Operating Procedures), WIs (Work Instructions), and master quality procedure system forms and templates] associated with the QMS (quality management system), management controls, design controls, purchasing controls, material controls, equipment controls, the CAPA system, production and process controls, document, design, and process controls and change management activities, and various process validation activities [including prospective validation IQ (installation qualification), OQ (operation qualification), PQ (process performance qualification), and PPQ (product performance qualification) areas, and concurrent and retrospective related validation protocols, reports, and other documentation].
• Audit, review and critique all QC and manufacturing related protocols and documentation.
• Audit, review and critique Risk Management program and deliverables [such as FME(C)A’s (failure mode, effects, (and criticality) analyses), FTA’s (fault tree analyses), etc.].
• Audit, review and critique manufacturing program procedures, sampling, and processes.
• Participate and represent Regulatory Compliance in various Design, Quality, Regulatory, and Manufacturing meetings (such as pertaining to post-market assessment and surveillance activities, material reviews, nonconforming product and process identifications, evaluations, dispositions, control, corrections, corrective actions, and/or preventive actions).
• Knowledgeable in various domestic and international laws, regulations, directives, standards, and guidance (including FDA, Health Canada, EU, Australian, Brazilian, Japanese, and Chinese medical device and combination product requirements).
• Train and Qualify quality, regulatory, operational/ production, and administrative personnel related to the design, manufacturing and test processes and other quality system requirements.
• Work with ISO/EU/CE Mark, FDA, Health Canada, and other public health and industry personnel, documentation, systems, operations, and requirements.
• Revise, prepare, audit, review and critique Multi-level SOP, BOM (bill of material), and ECO (engineering change order) process instructions and records.
• Audit, review and critique SPC (statistical process control) and QC/QA related protocol and documentation.
• Skilled in New Product Introduction (NPI) and CE mark certification processes.
• Audit, review and critique validation SOPs and policies according to cGMPs (current good manufacturing processes) for aseptic process validation, sterilization validation (steam, gamma, EtO, dry heat, chemical, etc.).
• Audit, review and critique large and small subsidiaries and vendors for set-up and transfer of products to headquarters and vendor sites.
• Audit, review and critique schematics, blueprints and build instructions for various medical devices, including in-vitro diagnostics, orthopedic, electrical and mechanical devices.
• Audit, review and critique purchasing control records and operations and software and hardware validations.
• Audit, review and critique Failure mode effect analysis of product design specifications and documentation.
• Monitor, maintain, audit, review and critique Corrective action and process document processes.
• Audit, review and critique Design review FME(C)As, FTAs, and other risk analysis tools and corresponding risk management activities, processes, and documentation for new and revised product design analyses.
• Audit all major inspection, measurement, and test equipment (such as scopes, logic analyzers, spectrum analyzers, etc.).
• Audit all major production equipment (such as CNC machines, packaging machines, sterilizers, etc.).

REGULATORY EXPERTISE
All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Non-Mechanical Medical Devices- Durable, Electronics, Implantables, IVDs (In-Vitro Diagnostics), Lasers, Software, Cataract systems, Oncology systems, Coated Stents, Steerable Catheters, Over the wire (OTH), Rapid Exchange (RX) Stent delivery systems (STS), Pacemakers, Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants. Adverse Event Evaluation, Audits -Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA - 483 and Warning Letter Responses/Consent Decree, GMP, Hazard Analysis, ISO - 13485/ 9001/9002/ 9003/14971 (Risk Management), EU Active Implantable Medical Device Directive (AIMD) / EU In-vitro Diagnostic Directive/ EU Medical Device Directive (MDD)/ EU Medical Device Regulation (MDR), Regulatory Compliance, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, and Working Knowledge of FDA Field and HQ Staff, Websites, Databases, Procedures, and Operations.

TECHNICAL QUALIFICATIONS AND ADDITIONAL TRAINING
Familiar with the working of various FDA medical device databases, MAC/PC Applications, MS Office applications (such as MS Word, Excel, PowerPoint, Outlook, and Visio), and various medical device/ industry automated systems (such as Verse, ETQ, TrackWise, and Device Events). Additional training includes: QSIT (Quality System Inspection Technique) Basics, Computer Aided Inspections, Computer Systems Validation, FMEA Workshop, Auditing Medical Devices, Medical Device Process Validation, Quality Audits for Improved Performance, Industrial Sterilization for Drugs/ Devices, and Orientation to International Inspections.


*Note: Many more employment positions- list available upon request.

Expert may consult nationally and internationally, and is also local to the following cities: South Bend, IN

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Education

Year Degree Subject Institution
Year: Degree: Doctor of Business Administation (all but dissertation) Subject: International Business Institution: South University
Year: 2017 Degree: MS Subject: Regulatory Affairs for Drugs, Biologics, and Medical Devices Institution: Northeastern University
Year: 1999 Degree: MBA Subject: International Business Institution: Indiana University
Year: 1989 Degree: BS Subject: Metallurgical Engineering Institution: University of Notre Dame
Year: 1982 Degree: BS Subject: Chemistry Institution: University of Notre Dame

Work History

Years Employer Title Department Responsibilities
Years: 2019 to Present Employer: Undisclosed Title: Expert Consultant Department: Responsibilities: • Provided various professional up-to-date cannabis, medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provided various professional regulatory compliance and quality assurance consulting and contracting activities as a Regulatory Compliance Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.

November 2019
• Provided technical quality and regulatory training with a subject matter expert in the area of basic quality and regulatory compliance, quality systems, and quality analytics to operations and administrative personnel of an international manufacturer of single-use and reusable passive thermal packaging.

November 2019
• Provided technical quality and regulatory training with a subject matter expert in the area of basic quality and regulatory compliance, quality systems, and quality analytics to operations and administrative personnel of a domestic non-profit organization that partners with charitable organizations in fundraising and support.

October 2019- December 2019
• Assisted quality, regulatory, operations, and logistics subject matter experts with the initial setup of an international cannabis manufacturing company (including meeting with key Thai cosmetic and packaging/ labeling suppliers and warehouse owners in December 2019).
Years: 2018 to 2019 Employer: Maetrics, LLC Title: SENIOR ASSOCIATE Department: Responsibilities: • Provided various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provided various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.

October 2018
• Performed a supplier audit under U.S. FDA cGMP pharmaceutical laws and regulations (including 21 CFRs 11, 210, and 211).

November 2018
• Performed a supplier audit under U.S. FDA QSR medical device laws and regulations (including 21 CFRs 11, 803, 806, 820, 821, and 830).
Years: 2017 to Present Employer: Undisclosed Title: CONTRACT CfPA COURSE DIRECTOR/ MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides professional level accredited and continuing education training in a variety of course formats, including in person, customized client site, and interactive online, pertaining to various up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business subjects to individual, corporate, legal, and governmental clients when requested and as needed.
Public Training: Quality Management and Compliance in the Pharmaceutical and Related Industries
September 2017, Burlingame, CA
• Provided technical quality system training in the area of pharmaceutical and medical device quality management and compliance to interested clients
Years: 2017 to Present Employer: Undisclosed Title: INDEPENDENT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
Medical Device and Combination Product Manufacturer
November 2019- December 2019
• Performed mock FDA level II QSIT Audit per FDA laws, regulations, standards, and guidance documents.
Webinar: Medical Device Quality Auditing
December 2017
• Provided webcast medical device quality auditing training to interested parties.
Years: 2017 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides professional training and consulting to corporate, legal and government clients as a Medical Device and Combination Products Consultant when requested and as needed.
Webinars: FDA Warning Letters: Remediation Strategies Expert Panel Discussion & CAPA Remediation Strategies
August 2017- September 2017
• Provided online technical panel discussion FDA warning letter reconciliation training to interested parties.
• To provide online technical FDA warning letter reconciliation training primarily in the area of the Medical Device CAPA system to interested parties. (To be conducted at a later date.)
Years: 2016 to 2017 Employer: FARLA Medical Title: REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT/ QUALITY AND REGULATORY MANAGER Department: Responsibilities: Medical Device, Pharmaceutical, and Combination Product Own Label Product Distributor and Manufacturer/ Contract Manufacturer
• Determined FDA classification and regulatory scheme for various finished medical devices to be marketed in the US.
• To perform various regulatory compliance and quality assurance activities (such as noted below) as company's Quality and Regulatory Manager (To be conducted at a later date.)
o To work with FDA Quality and other companies so that applicable 510(k)s, NDAs, and/or ANDAs can be submitted to the FDA for various class 2 medical devices, combination products, and pharmaceuticals (To be conducted at a later date.)
o To register the company and list the applicable medical devices, combination products, and pharmaceuticals with the FDA via FURLS (To be conducted at a later date.)
o To oversee all quality and regulatory operations (including acting as the company’s management representative, overseeing and/or performing quality audits and gap analyses of the company’s quality system, etc.) (To be conducted at a later date.)

Years: 2016 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Basics of Medical Device Document and Change Controls
July 2016
• Provided online technical quality system training in the area of Medical Device Document and Change Controls to interested clients.
Years: 2015 to 2015 Employer: TSK Laboratory, Japan, Tochigi-Shi, Japan and Tochigo Seiko Co., Ltd., Tochigi-City, Japan Title: CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: Medical Device Manufacturer: TSK Laboratory, Japan, Tochigi-Shi, Japan and Contract Manufacturer: Tochigo Seiko Co., Ltd., Tochigi-City, Japan
• Supplied various medical device quality assurance and regulatory compliance guidance and assistance when requested.
• Performed various reconciliation/ FDA readiness activities associated with upcoming FDA level II QSIT inspection.
• Revised/ created quality system procedures using FDA laws, regulations, standards, and guidance documents.
• Supplied various medical device quality assurance and regulatory compliance training, guidance and assistance when requested.
• Trained company engineering, production, and regulatory/quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, document and change controls, and facility and material controls)
• Performed mock FDA level II QSIT Audit per FDA laws, regulations, standards, and guidance documents.
• Assisted with various FDA readiness activities, including overseeing QSIT subsystem teams, facility revisions, and procedural and document revisions.
• Assisted in various FDA inspection backroom activities (including subject matter expert coaching).
Years: 2015 to 2015 Employer: Pharmabiodevice Consulting LLC Title: CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
Years: 2015 to Present Employer: Undisclosed Title: CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer and Contract Manufacturer: TSK Laboratory, Japan, Tochigi-Shi, Japan and Tochigo Seiko Co., Ltd., Tochigi-City, Japan
October 2015
• Performed various reconciliation/ FDA readiness activities associated with upcoming FDA level II QSIT inspection.
• Revised/ created quality system procedures using FDA laws, regulations, standards, and guidance documents.
• Supplied various medical device quality assurance and regulatory compliance training, guidance and assistance when requested.
• Trained company engineering, production, and regulatory/quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, and document and change controls)
• Performed mock FDA level II QSIT Audit per FDA laws, regulations, standards, and guidance documents.
Years: 2015 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Medical Device Quality, Quality Systems, and Regulatory Compliance
August 2016
• Provided online technical quality system training in the area of Medical Device Quality, Quality Systems, and Regulatory Compliance to interested clients.
Years: 2015 to Present Employer: Undisclosed Title: CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
Years: 2015 to Present Employer: Undisclosed Title: CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date).
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
Years: 2015 to Present Employer: Undisclosed Title: PRIMARY MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: Varian Medical Systems, Winnipeg, Manitoba, Canada
April 2015
• Revised purchasing control/ supplier audit quality system procedures using FDA, Health Canada, and EU laws, regulations, directives, standards, and guidance documents.
Years: 2015 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Corrective Actions and Preventive Action (CAPA) and How to Initiate, Handle, Monitor and Manage? April 2015
• Provided online technical quality system training in the area of Medical Device CAPA system to interested clients.
Webinar: Medical Device Design Controls: How to Handle, Monitor and Manage
June 2015
• Provided online technical quality system training in the area of Medical Device design controls to interested clients.
Years: 2014 to Present Employer: Undisclosed Title: CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: Olympus Corporation of the Americas, Southborough, MA
March 2020
• Performed an internal quality audit under U.S. FDA and ISO biological monitoring medical device laws, regulations, standards, and guidance (including 21 CFRs 50, 54, 56, and 812, ISO 13485:2016, and ISO 14155:2011).
Years: 2014 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE TRAINER Department: Responsibilities: • Provides technical and professional training to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Classroom training: Orthopedic Quality Standards and Technical Skills Certificate Program
March 2014
• Provided technical and professional FDA QSR and ISO 13485 Quality System training to interested personnel.
Years: 2014 to Present Employer: Undisclosed Title: PRIMARY MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
• Serves as an expert witness and/or litigation consultant offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services in various litigation areas (such as FDA and/or international Medical Device Quality Systems; Governmental and International Business Operations; Site Registration and Product Listing; Product Classification, Market Submission, Receipt, Acceptance, Design, Manufacturing, Nonconformance, Packaging and Labeling, Storage, Handling, and Distribution; Management Controls, Design Controls, Purchasing Controls, Document and Change Management Controls, Material Controls, Facility Controls, Equipment Controls, Production and Process Controls, and other quality, regulatory, and legal QSR/cGMP requirements).
Law Office (Confidential), Glendora, CA May 2017- Present
• Analyzes, investigates, and reviews court records, depositions and associated product servicing et al quality system documentation (including manufacturing company written procedures and quality data) pertaining to the improper servicing of medical device products and corresponding quality system procedures and quality records.
• Additional activities to be determined at a later date.
Law Office (Confidential), Winchester, MA May 2017- Present
• Analyzes, investigates, and reviews court records, depositions and associated product labeling/ storage/ handling/ et al quality system documentation (including manufacturing company written procedures and quality data) pertaining to the improper storage and handling of medical device products and corresponding quality system procedures and quality records.
• Additional activities to be determined at a later date.
Law Office (Confidential), Houston, TX January 2017- Present
• Analyzes, investigates, and reviews court records, depositions and associated CAR/ MDR/ complaint/ et al quality system documentation (including FDA MAUDE reports, 483’s, and warning letters and manufacturing company written procedures and quality data) pertaining to non-conforming medical device products and corresponding quality system procedures and quality records.
• Additional activities to be determined at a later date.
Law Office (Confidential), North Haven, CT June 2016- June 2017
• Analyzed, investigated, and reviewed court records, depositions and associated CAR/ MDR/ complaint/ servicing, et al quality system documentation (including FDA 483’s, warning letters, and consent decrees) pertaining to non-conforming medical device products and corresponding quality system procedures and quality records.
Years: 2014 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Basic Medical Device CAPA (Corrective Action and Preventive Action) System Concepts
February 2014
• Provided online technical quality system training in the area of Medical Device CAPA system to interested clients.
Years: 2014 to Present Employer: Undisclosed Title: CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: Zimmer USA, Warsaw, IN
January 2014
• Reconciled medical device design history files using FDA laws, regulations, and guidance documents.
Years: 2013 to 2013 Employer: Signature Orthopaedics Pty Title: CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT Department: Responsibilities: • Supplied various medical device quality assurance and regulatory compliance guidance and assistance when requested.
• Provided import training to various site personnel (online training via GO-TO-MEETING).
Years: 2013 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: Ad-Tech Medical Instrument Corporation, Racine, WI
October 2013
• Conducted quality plan reconciliation and improvement using FDA laws, regulations, and guidance documents.
Years: 2013 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: EKOS, Inc., Bothell, WA
September 2013
• Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.
Years: 2013 to 2013 Employer: Compliance Architects Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provided professional auditing as a contract Medical Device Quality Systems Auditor.
Contract Medical Device Manufacturer: Medicia, Dayton, NJ
September 2013
• Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.
Years: 2013 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Provides technical training & professional consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Understanding and Performing Medical Device Internal and External Quality Audits (Parts 1 & 2)
June & July 2013
• Provided online technical quality system training in the area of 1st, 2nd, & 3rd Party Quality Audits to interested clients.
Years: 2013 to Present Employer: Undisclosed Title: QUALITY DIRECTOR Department: Responsibilities: • Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, clinical, food, cosmetic, and tobacco product technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed (including various contract work for/at Hudson Scientific and Chemular).
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device, Pharmaceutical, Biologic, Combination Product, Food, Cosmetic, and Tobacco Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed (including various contract work for/at Hudson Scientific and Chemular).
• Acts as a Medical Device Quality and Regulatory Manager and Management Representative, Pharmaceutical and Biologic Quality Assurance Manager, and Food Preventive Controls Qualified Individual for various clients when requested and as needed.
Years: 2016 to Present Employer: Undisclosed Title: CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT Department: Responsibilities: • Works with other AUK Technical Services management and team members (as contractors and employees for Chemular, Inc.) and various Chemular management and staff to assist US and foreign e-cigarette clients to achieve compliance with industry, FDA and/or EU tobacco product regulations when requested and as needed.
Medical Device, Pharmaceutical, and Combination Product Contract Manufacturer and Medical Device Initial Importer: Hudson Scientific LLC, Hudson, MI
February 2016- October 2016 and March 2018- August 2018
DIRECTOR OF REGULATORY AFFAIRS, REGULATORY COMPLIANCE, AND QUALITY ASSURANCE/ MANAGEMENT REPRESENTATIVE
• Performed various regulatory affairs, regulatory compliance, and quality assurance work and assists onsite staff as needed and required.
• Acted as Director of Regulatory Affairs, Regulatory Compliance, and Quality Assurance/ Management Representative from March 2018- August 2018 (performed remotely at residence and at Hudson, MI).
• Acted as Quality and Regulatory Manager/ Management Representative from September 2016- October 2016 (performed remotely at residence and at Hudson, MI).
• Conducted various regulatory affairs, regulatory compliance, and quality assurance activities as the Regulatory Affairs, Regulatory Compliance, and Quality Assurance Director and Management Representative (as of March 28, 2018) from March 2018- August 2018 (performed remotely at residence and at Hudson, MI), including:
o Assisted company management and staff during an initial FDA cGMP pharmaceutical inspection.
o Performed various regulatory affairs, regulatory compliance, and quality assurance work and assists onsite staff as needed and required.
o Worked with other AUK Technical Services team members (as contractors and employees for Hudson Scientific) and various full-time and contract/ temporary Hudson management and staff to assist with start-up and continued operations so that the contract manufacturing company was following applicable FDA medical device, pharmaceutical, and combination product laws and regulations.
 Oversaw and performed the creation of draft quality system procedures.
 Advised company engineering and production department personnel in FDA medical device, pharmaceutical, and combination product requirements.
o Trained company engineering, production, and quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, and document and change controls).
o Performed 1st, 2nd, and 3rd party audits and gap analyses.
o Reviewed current quality system procedures and quality records for compliance against FDA medical device, pharmaceutical, and combination product laws and regulations.
o Trained, mentored, guided, and/or coached Hudson management and staff in current industry, FDA, and international medical device, pharmaceutical, and combination product laws, regulations, directives, standards, guidance, and requirements.
o Individually and/or with the assistance of Hudson management and/or staff, performed, oversaw, and/or managed nonconforming and out of specification medical device, pharmaceutical, and combination product, quality system, and process corrections, corrective actions, preventive actions.
o Individually and/or with the assistance of Hudson management and/or staff, performed, oversaw, and/or managed applicable medical device, pharmaceutical, and combination product document, design, and/or process changes (including new products and operations).
o Liaised with Hudson management and staff prior to, during and after all FDA, OEM, customer, and other regulatory body and industry quality and regulatory inspections, investigations, audits, and gap analyses, including applicable front and/or back room FDA inspectional readiness activities.
Years: 2018 to 2018 Employer: Medical Device Specification Developer: iTOVi Title: Independent Project Performed as AUK’s Quality Director Department: Responsibilities: • Oversaw and performed 21 CFR 803 MDR (medical device reporting) and 21 CFR 806.10 product removal operations for an unapproved, adulterated, and misbranded FDA class 2 medical device.
• Worked with other AUK Technical Services team members to transfer various specification developer operations to Hudson Scientific LLC.
• Worked with other AUK Technical Services team members to assist the company’s design control team with creating design control quality system procedures and a medical device design history file for a ‘redesigned’ FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members and various company management and staff to assist with operations so that the specification developer follows current and applicable FDA medical device laws and regulations (including developing draft quality system procedures and advising company management and personnel in current FDA medical device requirements.
Years: 2018 to 2018 Employer: Medical Device Manufacturer and Specification Develper: Konsyl Pharmaceuticals Title: Independent Project Performed as AUK’s Quality Director Department: Responsibilities: • Worked with other AUK Technical Services team members to transfer various manufacturing operations to Hudson Scientific LLC.
• Worked with other AUK Technical Services team members to assist the company’s design control team with creating design control quality system procedures and a medical device design history file for an FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members and various company management and staff to assist with operations so that the medical device manufacturer follows current and applicable FDA medical device laws and regulations (including advising company management and personnel in current FDA medical device requirements.
Years: 2017 to 2018 Employer: Medical Device Manufacturer: Nexgen Dental Milling Center Title: Independent Project Performed as AUK’s Quality Director Department: Responsibilities: • Worked with other AUK Technical Services team members to prepare and submit an abbreviated 510(k) premarket notification (PMN) submission for an FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members to assist the company’s design control team with creating design control quality system procedures and a medical device design history file for a FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members and various company management and staff to assist with start-up operations so that the manufacturing company is in compliance with current and applicable FDA medical device laws and regulations (including developing draft quality system procedures and advising company management and personnel in current FDA medical device requirements. (Additional activities to be conducted at a later date.)

Government Experience

Years Agency Role Description
Years: 1985 to 2006 Agency: U.S. Food and Drug Administration Role: ANALYST/ LEVEL II CERTIFIED INTERNATIONAL MEDICAL DEVICE INVESTIGATOR Description: Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to various FDA-regulated products, primarily within the medical device industry (including IVDs and radiological health products and industries), but also including human and animal foods, cosmetics, human and animal drugs, clinical/ BIMO, biologics, combination products, and other FDA and HHS regulated products).

International Experience

Years Country / Region Summary
Years: 2019 to Present Country / Region: Thailand Summary:
Years: 2015 to Present Country / Region: Japan Summary:
Years: 2010 to Present Country / Region: Taiwan Summary:
Years: 1991 to Present Country / Region: Western Europe- UK, France, Sweden, Denmark, Netherlands, Switzerland, Italy, Germany Summary:

Career Accomplishments

Associations / Societies
• 2017: ASCD (Association for Supervision and Curriculum Development) Student Membership
• 2017: FSPCA (Food Safety Preventive Controls Alliance) Preventive Controls for Human Food Certification for Preventive Controls Qualified Individuals (PCQI)
• 2010: ASQ (American Society for Quality) Certified Quality Biomedical Auditor (QBA)
Licenses / Certifications
• 2018-Present: Present: Doctor of Philosophy, International Business, South University, Savannah, GA (ongoing) (transferred due to school closure in March 2019 from Argosy University, Orange, CA)
• 2017: ASCD (Association for Supervision and Curriculum Development) Student Membership
• 2017-2018: Transition to Teaching Program courses, Bethel College, Mishawaka, IN
• 2017: FSPCA (Food Safety Preventive Controls Alliance) Preventive Controls for Human Food Certification for Preventive Controls Qualified Individuals (PCQI)
• 2015- 2017: Master of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Concentration in Regulatory Compliance (High Honors), Northeastern University, Boston, MA
• 2013- enKap/ Medical Device Academy Certificate of Participation Webinar: Conduct a More Efficient Management Review
• 2010: ASQ (American Society for Quality) Certified Quality Biomedical Auditor (QBA)
• 2013-2014: MS in Public Health (on-hold, to completed at a later date) with various courses taken online at Argosy University, Pittsburgh, PA
• 2006-2013: PhD in International Business (on-hold, to completed at a later date) with various courses taken online at Northcentral University, Chicago, IL; Walden University, Phoenix, AZ; Argosy University, Pittsburgh, PA, and South University, Savannah, GA
• 1991-1999: Master of Business Administration, Concentration in International Business, Indiana University, South Bend, IN
• 1984-1989: Bachelor of Science, Metallurgical Engineering, University of Notre Dame, Notre Dame, IN
• 1978-1982: Bachelor of Science, Chemistry, University of Notre Dame, Notre Dame, IN

Note: Expert has been granted a Substitute Teacher Permit from the Indiana Department of Education (expires 2021) and a Career Specialist Secondary Business Teaching Permit from the Indiana Department of Education (expires on 2022).
Awards / Recognition
• Master of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Concentration in Regulatory Compliance (High Honors), Northeastern University, Boston, MA
• enKap/ Medical Device Academy Certificate of Participation Webinar: Conduct a More Efficient Management Review

Additional Experience

Expert Witness Experience
Serves as an expert witness and/or litigation consultant offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services in various litigation areas (such as FDA and/or international Medical Device Quality Systems; Governmental and International Business Operations; Site Registration and Product Listing; Product Classification, Market Submission, Receipt, Acceptance, Design, Manufacturing, Nonconformance, Packaging and Labeling, Storage, Handling, and Distribution; Management Controls, Design Controls, Purchasing Controls, Document and Change Management Controls, Material Controls, Facility Controls, Equipment Controls, Production and Process Controls, and other quality, regulatory, and legal QSR/cGMP requirements).
Training / Seminars
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.

EDUCATION AND TRAINING
• 2018- Present: Doctor of Philosophy, International Business, Argosy University, Orange, CA (ongoing)
• 2017: ASCD (Association for Supervision and Curriculum Development) Student Membership
• 2017-2018: Coursework- Transition to Teaching (TTT) Graduate Education Program, Bethel College, Mishawaka, IN
• 2017: FSPCA (Food Safety Preventive Controls Alliance) Preventive Controls for Human Food Certification for Preventive Controls Qualified Individuals (PCQI)
• Master of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices, Concentration in Regulatory Compliance (High Honors), Northeastern University, Boston, MA
• enKap/ Medical Device Academy Certificate of Participation Webinar: Conduct a More Efficient Management Review
• 2010: ASQ (American Society for Quality) Certified Quality Biomedical Auditor (QBA)
• 1991-1999: Master of Business Administration, Concentration in International Business, Indiana University, South Bend, IN
• 1984-1989: Bachelor of Science, Metallurgical Engineering, University of Notre Dame, Notre Dame, IN
• 1978-1982: Bachelor of Science, Chemistry, University of Notre Dame, Notre Dame, IN

Other Relevant Experience
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.

Language Skills

Language Proficiency
English Native Speaker

Fields of Expertise

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