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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Open Innovation, New Product Development, Intellectual Property Management, Technology Strategy
Experienced leader of new product development, technology strategy and development, open innovation, alliance management, licensing, deal structuring and negotiation, intellectual asset management, competitive intelligence, consumer and sensory science. Proven results based on sound business and technical judgement and excellent relationship…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…
Sterile Processing, Team Building, Department Collaboration, Standardizing, PI, and Change Management
Expert is a diversely skilled Sterile Processing executive with over 34 year’s medical experience. Among other achievements, she has established department SOP -- and implemented, demonstrated and mastered LEAN processes. She eradicated IUSS -- formerly flash sterilization. She has also:…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…
Electron Beam Equiment for Sterilizing Medical Devices, and Irradiating Foods, Polymers and Wastes
Expert is one of two partners in a consulting firm. He is the former General Manager of AECL Accelerators. He planned and led the team that developed Atomic Energy of Canada's high energy, high power electron beam technology. He set…
Reproductive Medicine; Infertility, Reproductive Endocrinology
Expert J. Expert's residency training in Obstetrics and Gynecology was performed at The Stamford Hospital in Stamford, Connecticut. He then went on to complete his Postgraduate Fellowship in Reproductive Endocrinology and Infertility at The UCSD School of Medicine, San Diego,…
Gynecology, Minimally Invasive Surgery, Laparoscopy, Office surgery
Expert has pioneered many minimally invasive approaches to gynecologic surgical procedures in his region of Georgia. Having performed thousands of gynecologic surgical procedures, he has a broad range of expertise in laparoscopic, hysteroscopic, and vaginal approaches to gynecologic surgery. He…