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Medical Device Quality Assurance and Regulatory Compliance
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…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Global leader and serial entrepreneur in the medical device industry with multiple successes in building companies, teams, products, and revenues. Experienced at bringing new products to the world market in a high-growth dynamic environment. Experienced Board member and Chairman in…
Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer’s and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic’s regulations. Moreover, her firm has extensive experience in…
Public Relations and Government Relations
Expert is Principal and Chief Magnifier of his consulting company. He is the driving force behind its success. He is an experienced event planner, public and media relations expert. He is able to call upon close to thirteen years of…
Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…
Personal Care Cosmetics, Skin & Underam Care-Formulation Development-Application-Claim Support, INC Regulations, Ingredients, Formulation, Expert Witness
Besides working as Senior Principle Scientist for Kao Brands (Curel Technical Brand Mgr, Jergens Technical Leader, Ban AP innovation, John Frieda Innovation), Expert has worked for Dow Corning as a Senior Technical Service Scientist in the field of silicone chemistry,…
Medical Device Product Development; Machine Design; Biomedical Engineering
Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. The research included materials, methods of molding, color changes, and effects on biocompatibility. His library contains many materials…
Change Management, Organizational Design, BPM, Project Management Office, Planning and Performance
Commercial and Engineering Science (HEC – Liege), MBA – Strategic Planning (Liege University) and Over 25 years in management and consulting worldwide (Canada, Belgium, Germany, Russia, Morocco, Egypt, Lebanon, Saudi Arabia, other Gulf countries, Colombia). Expert is a pioneer in…
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…