REGULATORY

Regulatory Affairs professional with 19 years of experience working with government and industry. Significant experience in product development, analysis and reporting of medical product technical data and applications for use in human healthcare planning and management. After significant experience in Quality Assurance, Marketing, Product Development, and Project Management activities, I have focused on Regulatory Affairs activities obtaining global registrations for over 200 medical devices, becoming familiar with international registration requirements. Working in industry, I have developed positive and effective relationships with public health authorities at local, state, and federal levels to establish innovative policy and safe practices for health services and products... As team leader and director of regulatory affairs in both well-established corporations (Roche/Ventana Medical Systems, Covidien/Medtronic) and successful entrepreneurial organizations (Biodesix, InDevR), I..