Expert Details

Expert in Medical Device Regulatory Submissions

Expert ID: 725331 California, USA

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She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success.

Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic and Cosmetic Lasers; Microwave Cardiac Surgery Systems; X-Ray Therapeutic Systems; and Blood Glucose Monitoring Devices.

She is well versed in the Food and Drug Administration's medical device regulation including Current Good Manufacturing Practice and FDA's current Quality System Regulation, as well as Investigational Device Exemption Regulations. She also has extensive experience in foreign device registrations including device testing to standards and electromagnetic compatibility testing.

Some of the device types she has experience with include Surgical Instrumentation, Electrosurgical Units and accessories, Cardiac Ablation Systems and Catheters;

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 1997 Degree: B.Sc. Subject: Biological Science Institution: University of California, Davis
Year: 1987 Degree: AA Subject: Business Administration, accounting emphasis Institution: American River College

Work History

Years Employer Title Department Responsibilities
Years: 2006 to Present Employer: Undisclosed Title: Managing Consultant Department: Regulatory and Quality Consulting Responsibilities: Consulting in Regulatory Affairs and Project Management, including product strategy, global submissions, technical writing, FOIA requests, and product submissions.
Years: 2005 to 2006 Employer: Guidant Cardiac Surgery Title: Senior Associate Department: Regulatory Affairs Responsibilities: Evaluate changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write regulatory assessments. Support IDE activities for Cardiac Surgery products. Research, write, and file submissions to FDA for product marketing clearance or approval, and negotiate with FDA during product review cycle. Represent Regulatory Affairs on Change Control Board and Product Development Teams. Train, mentor, and supervise other associates (1 direct report).
Years: 2004 to 2005 Employer: TheraSense, Inc./Abbott Diabetes Care Title: Senior Associate Department: Regulatory Affairs Responsibilities: Evaluate new products as well as changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write corresponding regulatory assessments. Research, write, and file submissions (510(k) and PMA) to appropriate FDA or appropriate regulatory group for product marketing clearance or approval, and negotiate with FDA during product review cycle. Safety Complaint Review and MDR determination. Support international groups with product filings and approvals. Represent Regulatory Affairs on Change Control Board and Product Development Teams. Train and mentor other associates in regulatory requirements.
Years: 2003 to 2004 Employer: Lumenis, Ltd. Title: Senior Associate II Department: Regulatory Affairs Responsibilities: Responsible for regulatory activities of Aesthetic Business Unit. Evaluate new products as well as changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write corresponding regulatory assessments. Research, write, and file submissions to FDA for product marketing clearance or approval, and negotiate with FDA during product review cycle. Support of international groups for product filings and approvals. Safety complaint evaluation and MDR/Vigilance reporting.
Years: 1998 to 2003 Employer: Boston Scientific Corp./EP Technologies, Inc. Title: Senior Associate Department: Regulatory Affairs Responsibilities: Research, write, and file submissions to FDA for product marketing clearance or approval, and negotiate with FDA during product review cycle. Represent Regulatory Affairs on Quality System Review Board, Change Control Board and Product Development Teams. Evaluate new products as well as changes to existing products to determine regulatory impact, plan appropriate regulatory strategies, and write corresponding regulatory assessments. Research Regulations relating to products, and communicate regulatory requirements to other organizational departments. Train and mentor other associates in regulatory requirements.
Years: 1998 to 1998 Employer: Neurex Corporation Title: Quality Assurance/Regulatory Affairs Documentation Coordinator Department: Quality Assurance Responsibilities: Designed databases for document & data tracking relating to FDA compliance and company's Quality System. Wrote policy & procedure documents regarding software validation. Set up database for tracking of Adverse Events, and other clinical trial data. Responsible for formatting, editing, and control of QA documents. Maintenance of Company documents and archive for Regulatory Submissions (NDA).
Years: 1996 to 1997 Employer: Applied Imaging Corporation Title: Quality Systems Analyst Department: Responsibilities: Began tenure in Quality Assurance/Regulatory Affairs as Document Control Clerk, advanced to Systems Analyst - reported to Director of Regulatory Affairs. Acted as Coordinator for Regulatory Submissions. Created database for tracking documents relating to FDA GMP and ISO 9000 compliance, including Quality Manual, DMRs, and DHFs to ensure document files were in compliance. Set up database for regulatory tracking of Customer Complaints and System Performance Reports. Formulated company procedure and policy documents regarding QA Documentation, MIS, and Help Desk. Participated in formation of formal MIS Group. Created, coordinated, and operated Help Desk functions for corporate headquarters. Organized weekly training seminars on computer use. Completed training in technical writing, documentation, Quality Assurance Principles, and ISO Internal Auditor Certification.

Career Accomplishments

Associations / Societies
Project Management Institute,
American Society of Notary Publics,
RAPS - RAC Candidate,
Healthcare Businesswomen’s Association,
ASQ.
FDLI
Licenses / Certifications
ISO 13485 (2003) Auditor Training.
ISO 9000 Documentation and Auditor Training.
European Medical Device Regulations (TUV).
IIR - Computer and Software Validation.
FDA Inspections of Regulated Industry Manufacturers (FDLI).
Dale Carnegie Course.
Medical / Professional
Food and Drug Law Internship (FDLI)

Additional Experience

Training / Seminars
Provided and delivered training courses on Design Control, Vendor Selection and Management, Quality System Regulations, Risk Management, Regulatory Submissions
Vendor Selection
Certified Quality Auditor, have performed supplier audits for contract manufacturing sites world-wide. Have sourced and qualified vendors to ASL/AVL.
Marketing Experience
20 years Regulatory Affairs experience involving the development of complex and novel medical technologies from concept to product retirement including the following submissions:
Contributed to seven PMAs including Modules, Supplements and Annual Reports
IDE’s (and IDE Reports),
Numerous 510(k)’s (traditional, abbreviated, and special),
EU Design Dossiers and Technical Files; and Other International Documentation (Asia Pacific and Latin America).
Other Relevant Experience
Over 10 years experience with cross-functional team environments, roles ranging from support:
Cardiac Catheters and Capital Equipment (RF and Ultrasound); including software, Laser Catheters and Capital for Cardiac, Surgical and Aesthetic Use; including software, Surgical Ablation Catheters and Capital Equipment (Microwave)
Blood Sugar Monitoring Systems, both meter/strip and continuous; including software
Visualization Systems; including capital equipment and software.

Fields of Expertise

510(k) document, ablation, surgical instrument, therapeutic device, Current Good Manufacturing Practice, electromagnetic compatibility, FDA medical device regulation, investigational medical device exemption regulation, cardiac electrophysiology, electrosurgical instrumentation, endometrial ablation, tracheal intubation, health care quality assurance, cardiac ablation, neurosurgical device, regulatory affairs, change control, cardiac care, archival system, cardiac surgery, business management, chronic obstructive pulmonary disease, catheter tubing, Safe Medical Devices Act of 1990, phototherapy, cosmetic product development, clinical measurement, Food and Drug Administration compliance, biocompatibility testing, cannula, Food and Drug Administration validation, guidewire, photodynamic therapy, Medical Device Reporting regulation, clinical trial design, disposable surgical product, durable medical equipment, biomedical application, plastic medical device, catheter equipment, ablative photodecomposition, ablation threshold, medical regulation, electrical medical treatment, electrocoagulation, electrocautery instrument, dilator, cauterization, cardiac catheterization, catheterization, fiber-optic component product development, rapid product development, Food and Drug Administration chemical registration, foreign medical device regulation, disposable medical device, respiratory therapy, product development cycle time, electrical product development, device product development, photoablation, design for manufacturability, new product development, nuclear-powered artificial cardiac pacemaker, electronic product development, Food and Drug Administration, Federal Communication Commission, new product development management, electronic medical device, electrocardiograph, Food and Drug Administration regulation, device code, radiation therapy, medical instrument, biomedical instrument, computer, project management, artificial cardiac pacemaker, ophthalmology, medical device, biomedical diagnostic instrumentation, cryosurgery, clinical trial, catheter, biomedical sensor, bioinstrumentation

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