Mark Gordon Email & Phone Number

Mark Gordon has over 45 years experience in the medical device industry, focused on Regulatory Affairs, Clinical Affairs, Quality Assurance, and Research and Development.Mark has previously held senior leadership positions at Outset Medical, Alcon, Abbott, Synthes/Johnson & Johnson, Boston Scientific, and Medtronic, as well as early-stage organizations, in the cardiac, cardiovascular, orthopedic, ophthalmologic, and dialysis sectors. In these global roles, Mark has established a track record of successful leadership, transforming functional teams towards excellence, strengthening relationships and resolving challenges with regulatory agencies, establishing forward-leaning regulatory strategy with timely regulatory approvals, effectively managing preclinical and clinical investigations, and sustaining lean and compliant quality systems. He has led the worldwide regulatory efforts on the buy and sell side for M&A deals ranging from $100 million to more than $25 billion in individual value, and has presented best-practices for regulatory due diligence in multiple forums.Mark has served as a Board Advisor for early stage companies, as a member of the Board of Directors of National Alliance for Eye and Vision Research (NAEVR/AEVR), and as Chairman of the RAPS Board of Directors. He is a long-standing member of the MDMA FDA Strategy Group, and has served as Co-Chair of the AdvaMed Technology and Regulatory Group. He has served as industry representative for four FDA MDUFA negotiations and associated US Congressional reauthorizations, and as a member of Global Harmonization Task Force (GHTF) Study Group 5 (Clinical Studies). He is a RAPS Regulatory Affairs Fellow accomplishing US and EU RAC, and is a Senior Member of ASQ. Mark received a Bachelor’s and Master’s degree in Bioengineering from the University of California, San Diego.

Listed skills include Medical Devices, Biotechnology, Regulatory Affairs, Global Regulatory Strategy, and 36 others.