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

Contact this expert witness

This licensed registered nurse has been in his field for over 27 years. He earned his AS in nursing from Virginia Appalachian College and is a certified legal nurse consultant. He is also certified in basic life support and advanced ...

Life Care Planning Expert

E-036013
State: NY
    Specialties:

This highly-qualified expert has more than 25 years of experience as a life care planner and a nurse case manager. She received a diploma in nursing from Mount Vernon Hospital School of Nursing before earning her BS from Oklahoma City ...

Respiratory Therapy Expert

E-647258
State: GA
    Specialties:

This expert is located in Georgia and has nearly 15 years of experience as a registered respiratory therapist. She earned her BS in respiratory therapy and her MPH both at Georgia State University. She later attended Mercer University ...

New Search