Zach Rothstein is Executive Director for AdvaMedDx. In this role, Zach directs the policy, advocacy, communications, regulatory, payment and legislative strategy and operations of the association, which represents manufacturers of in vitro diagnostic (IVD) clinical tests in the U.S. and abroad. Prior to this position, Zach was AdvaMed’s Senior Vice President for Technology and Regulatory Affairs where he led the association’s efforts on digital health, software, cybersecurity and postmarket policy matters. Rothstein also participated in all aspects of the MDUFA V negotiation process, and served as AdvaMed’s lead coordinator for its COVID-19 Action team. Zach is also a member of the World Health Organization’s Digital Health Technical Advisory Group’s Roster of Experts.
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. 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.