Zach Rothstein Email & Phone Number

Zach Rothstein is a strategic leader and problem-solver with deep expertise in the legal and regulatory environment of the medical device industry. As the Executive Director of AdvaMedDx, Zach leads a multidisciplinary team of experts in representing the In Vitro Diagnostics (IVD) industry on complex policy, regulatory and legal matters in the US and abroad. Prior to this position, Zach served as AdvaMed’s Senior Vice President for Technology and Regulatory Affairs where he led the medical technology industry’s initiatives on digital health, software/AI, cybersecurity and postmarket policy. He also participated in all aspects of the MDUFA V negotiation with FDA, and as the Lead Coordinator for AdvaMed’s COVID-19 Action Team, helped guide the industry through the unprecedented legal and regulatory challenges of the COVID-19 pandemic. Zach is also recognized as a leading expert on the legal and regulatory aspects of artificial intelligence (AI) and software as a medical device (SaMD). With over a decade of experience in this space, he has been a key player in shaping forward-thinking policies that facilitate the integration of these advanced technologies into the healthcare system, transforming patient care and operational efficiency. Prior to joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy at Samsung Electronics where he was responsible for the company’s medical device and healthcare regulatory and policy issues. In this position, Zach counseled Samsung’s global business units through all stages of product development on U.S. regulations affecting medical devices. Zach also planned and executed the company’s FDA and healthcare regulatory and legislative policy objectives. While at Samsung, Zach served on the Board of Directors for the Personal Connected Health Alliance (formerly Continua) and the Consumer Electronics Association’s Health and Fitness Technology Division. Prior to joining Samsung, Zach was an attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP. In this role, Zach served as outside counsel to various healthcare companies on FDA and HHS regulatory, compliance, and enforcement matters. Zach earned his J.D. cum laude from The Catholic University of America, where he was a Notes and Comments Editor of the Law Review, President of the Moot Court Board, and won first place and best brief awards at the 2009 National Telecommunications Moot Court Competition. Zach received his B.A. in political science and criminal justice from Indiana University, Bloomington.

Listed skills include Regulatory Affairs, Legal Research, Litigation, Legal Writing, and 15 others.