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David Chadwick, PhD, RAC, FRAPS

Regulatory Scientist
Independent

David E. Chadwick, PhD, RAC, FRAPS
Cook Medical, Bloomington, IN

I have over 25 years of experience in the medical device industry in such areas as basic research and development, clinical research, and for the past 20 years, regulatory affairs/quality assurance. The scope of my experience includes the product areas of dermatology, in vitro diagnostics, urology, cardiology, ENT devices, drug delivery, electrosurgery, cardiovascular stents and catheters. I spent many years in research and development functions and managing clinical trials prior to transitioning into regulatory affairs. My primary focus resides in medical devices and combination products, but my experience also expands into drug regulation and submission.

Over my regulatory career, I have been responsible for registration, compliance and complaints. I have served as the regulatory and clinical focus person for post-market activities and customer feedback.

I have extensive experience as an instructor at the Medical School level in Human Anatomy/Embryology and Histology. Additionally, I have experience at the undergraduate and technical school levels in Anatomy/Physiology and Cell Biology. I am a recognized lecturer for the Regulatory Affairs Professional Society and other organizations on a local, national and international level.

I am a member of the RAPS Board of Directors. I serve as the Industry Representative (alternate) to FDA’s Circulatory System Devices Panel and previously served as on the FDA's Ear, Nose, and Throat Devices Panel .

I have a B.S. in Biology from Albright College, and Ph.D. in Anatomy and Cell Biology from the School of Medicine, University of Pittsburgh. I have been recognized as a Fellow and hold the RAC certification.

Disclosure information not submitted.

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