Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. for both major medical device corporation and start up cardiovacual device companies. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel. Additionally, a seasoned educator/speaker with over 150 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Holds regular Webinars on FDA Issues, and routinely serves as an Expert Witness in the area of FDA regulation of medical devices.
FDA Medical Devices
Food Safety
Product Safety
Products Labeling and Warnings
Biotechnology
Government Regulation
Healthcare
Cardiovascular
Devices and Equipment
Medical Devices
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Your Messages Your ContactsOne Way Consultants LLC - East Alton, IL, United States
Principal Consultant
Advise medical device companies on FDA requirment
United States Food and Drug Aministraton - Los Angeles, CA, United States
Investigator, Supevisory Investigator , Compliance Officer, Director of Import Operations
Evalute FDA regulated industirie for compliance with FDA law and regulations
Medical Device Deveopment Coporation - Fullerton, CA
Founder/CEO
Worked with small medical device firms to develop devices meeting FDA rquirments
CORDIS WEBSTER, INC. a Johnson & Johnson Company, Baldwin Park, CA 91706 - Baldwin Park, CA, United States
Vice President, Regulatory Affairs, Clinical Research, and Quality Assurance,
Oversaw all compny FDA regulated operations (QA, RA and Clinical)
CARDIMA CORPORATION, Fremont, CA 94538 - Fremont, CA, United States
Vice President, Regulatory Affairs, Clinical Research, and Quality Assurance
Start up electrophysiology device firm. Set up quality systesm, wrote regultory submissions
CARDIAC PATHWAYS CORPORATION, Sunnyvale, CA 94086 - Sunnyvale, CA, United States
Vice President, Regulatory Affairs/Quality Assurance,
Start up electrophysiology device firm. Set up quality systesm, wrote regultory submissions
BAXTER HEALTHCARE CORPORATION, Edwards LIS Division - Irvine, CA, United States
Vice President, Regulatory Affairs, Clinical Research, and Quality Assurance, 1
Senior Executive directing Regulatory, Quality Assurance and Cinical Affairs assuring FDA Copliance
RETROPERFUSION SYSTEMS, INC., Costa Mesa, CA - Costa Mesa, CA, United States
Vice President, Regulatory Affairs, Clinical Research and Quality Assurance
Start up electronic cariovascular device firm. Set up quality systesm, wrote regultory submissions
UNITEK CORPORATION, Subsidiary of Bristol-Myers Company, - Baldwin Park, CA, United States
Manager, Regulatory Affairs
An estblshed ortodontic company, Over saw regulatory and emolyee safety programs Wrote regulatory submissions
HEYER SCHULTE DIVISION, American Hospital Supply Corporation, - Goleta, CA, United States
Manager, Regulatory and Clinical Affairs
Established manfacturer of silicone implants, Managed Regulatory and clinical deparments and assured FDA compliance.
United States Food and Drug Administration - Los Angeles, CA, United States
Investigator, publc health edcuator, small busines representative
Inspected FDA regualted businnses, educated public on FDA related health issues, provice regulatory guidance to small medical device firms
California State University Fullerton - Fullerton, CA, United States
BA Biological Sciences
Certified in Regulatory Affairs (RAC) by the Regulatory Affairs Professionals Society,
Jun 1991 - Present
Don’t use FDA to Rate Your Quality System
Published 2016
LinkedIn (2016 Feb. 24) 08/01/2016
What to Expect When You are Inspected.
Published 2004
Endovascular Today, 2004 Jan; 3(1):58-60
Design Verification.
Published 1994
Medical Device & Diagnostic Industry. 1994 Jan:93-97
Practical Aspects of the Clinical Evaluation of a Medical Device.
Published 1985
Medical Device & Diagnostic Industry. 1985 Apr: 7(4):71-75.10/15/2015
Regulatory Afffairs Progessons Society
Jun 1981 - Present
FDA Special Achievement Award, FDA Office of Criminal Investigations
2009
FDA Commnedable Service Award
1974
Member, Board of Directors, National Alliance on Medical Illness, Southern Illinois Division, August, 2011 to 2019
A non-profit organization offering assistance to persons or families dealing with mental illness, and advocating on their behalf.
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