FDA Regulation of Medical Devices Expert Witness
FDA Regulation of Medical Devices | E-611415
Expert Qualifications
This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.
Bio Snapshot
Location: IL
BA, Biological Sciences, California State University
Certified, Regulatory Affairs (RAC)
Member, Regulatory Affairs Professionals Society
Member, American Society for Quality
Member, FDA Alumni Association
Member, National Alliance on Medical Illness
Former, Consumer Safety Officer/Investigator, U. S. Food and Drug Administration
Former, Consumer Affairs Officer, U. S. Food and Drug Administration
Former, Representative, Small Business, U. S. Food and Drug Administration
Former, Manager, Regulatory and Clinical Affairs, American Hospital Supply Corporation
Former, Manager, Regulatory Affairs, Unitek Corporation-Bristol-Myers Company
Former, Vice President, Regulatory Affairs, Clinical Research & Quality Assurance, Retroperfusion Systems Inc.
Former, Vice President, Regulatory Affairs, Clinical Research & Quality Assurance, Baxter Healthcare Corporation
Former, Investigator, Medical Device Specialist, FDA Los Angeles District
Former, Compliance Officer, FDA Los Angeles District
Former, Director, Import Operations, FDA Los Angeles District
Former, Supervisory Investigator, FDA Saint Louis Office
Current, Consultant, a private consultancy for FDA regulated businesses in IL
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