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
