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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