FDA Medical Device Regulatory Requirements Expert Witness
FDA Medical Device Regulatory Requirements | E-030330
Expert Qualifications
This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.
Bio Snapshot
Location: St. Louis/IL
BA, Biological Sciences, California State University
MBA, Golden Gate University
Certification: Regulatory Affairs
Member, Regulatory Affairs Professionals Society
Member, American Society for Quality
Published, 3 Journal Articles
Lecturer, 250+ Professional Conferences
Former, Small Business Representative, US Food & Drug Administration
Former Vice President RA/QA/Clnical Cordis Corporation
Former, Vice President of Regulatory Affairs, Johnson & Johnson Company
Former, President/Founder, Medical Device Development Corporation
Former, Investigator, Medical Device Specialist, Food & Drug Administration - Los Angeles
Former, Compliance Officer, Food & Drug Administration - Los Angeles
Former, Director, Import Operations Branch, Food & Drug Administration - Los Angeles
Former, Supervisory Investigator, Food & Drug Administration - St. Louis
Current, Industry Consultant, Food & Drug Administration Consulting Corporation
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