Dcn Bios > Regulatory Affairs Professional
Regulatory Affairs Professional
RAC certified in both United States and European Union regulatory affairs by the Regulatory Affairs Professionals Society, of which he has been a member since 1997. Over 20 years’ experience in the medical devices and diagnostics industries in various roles, including product development, manufacturing, quality and regulatory affairs, augmented by over 9 years of direct experience in a regulatory affairs role in FDA-regulated industry. Knowledgeable of the regulatory requirements for devices and diagnostics in the major OUS markets, and has obtained market clearances in a number of foreign countries. He is a member of the American Society for Quality (ASQ) and is an ANSI/RAB-accredited auditor of quality systems for the medical device industry.