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A Quality Assurance and Regulatory Affairs professional with over 40 years of experience in the biotech industries, including pharmaceutical, medical devices, biologics and in vitro diagnostics. Effective in communicating and interacting with several domestic and international regulatory agencies in an ever changing regulatory environment. Hands on executive level individual with extensive experience in start-up, small and large companies, advancing products from concept to commercialization. Known to be extremely resourceful and able to facilitate and complete multiple projects in any situation. Successful track record with U.S. & International regulatory inspections of implemented Quality Management Systems.