Mark J Schwartz
Clinical & Regulatory Affairs
Mark is a proven leader in clinical and regulatory affairs in the medical device industry. He is a 25-year veteran of medical device clinical development, clinical and regulatory strategy, clinical study design and clinical study execution. Mark brings extensive leadership experience in the design and execution of clinical studies for medical devices and working with the FDA leading to regulatory approvals for novel technologies of industry leaders such as Boston Scientific, Sorin Group and Guidant, among others.
Mark comes most recently from EBR Systems, where he served as Vice President of Clinical and Regulatory Affairs for developing a leadless approach of cardiac resynchronization therapy for non-responders. Previously, he served as Senior Director of Clinical Affairs for Sorin Group, leading the U.S. clinical program for the company’s cardiac rhythm management and heart valve programs. There, he had oversight for IDE, research and post-market studies for a variety of cardiac devices, and was responsible for developing clinical, regulatory, market access and health economic strategies.
At Boston Scientific as Manager of Emerging Therapies, Mark was involved in the discovery, testing and clinical study of a portfolio of research and development projects, and as Manager of Clinical Programs, he successfully executed multiple clinical trials for heart failure, bradycardia and tachycardia product approvals. An engineer by training, his early career included bioengineering roles related to cardiac rhythm management devices for companies such as In Control and Intermedics.
Mark holds a Master of Science in Biomedical Engineering from The University of Texas at Arlington and a Bachelor of Science in Electrical Engineering from North Dakota State University. He is an innovator on more than 15 issued patents and multiple peer reviewed clinical publications.