Michael J. Billig
Regulatory Affairs Lead, UCSF-STanford Pediatric Device Consortium
CEO, Experien Group, LLC
Michael Billig is CEO of regulatory consulting firm Experien Group, LLC, in San Jose, CA and Regulatory Affairs Lead for the PDC. In this role, he will provide access to his extensive regulatory and quality assurance network.
Mr. Billig has over 35 years of experience in the medical device industry and has held executive-level positions for over 25 years in the areas of regulatory, quality, and clinical affairs. For a wide range of medical technologies, he has secured hundreds of U.S. clearances and approvals, including 510(k)s, IDEs, HDEs, and PMAs. Mr. Billig regularly represents medical device startups and client companies at FDA interface, notified body negotiations, board of directors’ meetings, and due diligence activities. Recently, Mr. Billig has been involved in the FDA Innovation Pathway Program at CDRH, as well as the pilot program for Early Feasibility IDEs.
For the past 10 years, he has also served as the acting Vice President of Regulatory, Quality, and Clinical for a number of Experien Group’s clients. On this company’s behalf, he obtained clearance for a cardiovascular implant to treat congenital heart defects in pediatric patients, as well as a recent HUD approval for a new product in the company’s pipeline.