VP Regulatory and Quality Services
EdgeOne Medical
Jerzy Wojcik is Vice President of Regulatory and Quality Services at EdgeOne Medical Inc., and has over 25 years of industry experience in quality and regulatory leadership within the medical device and pharmaceutical industries. His expertise includes identification and execution of regulatory activities across all stages of product development and lifecycle management, with a focus on medical devices and combination products with device constituents- including wearable sensors and mobile medical applications. He has particular strength in creating integrated development strategies that align regulatory requirements, quality management, product development and strategic partnerships to support innovative product development approaches. Jerzy also has expertise in US distribution and dispensing compliance, as well as regulatory surveillance for drug, biologics and devices. In addition to regulatory responsibilities, Jerzy also helped develop and implement quality systems and various process quality compliance initiatives. Mr. Wojcik has a Bachelor of Science in Biology, Medical Technology and Cytotechnology from Augustana College, IL, and was an Adjunct Professor in the School of Law at Northwestern University, IL. He is a member of Regulatory Affairs Professional Society (RAPS) and volunteers with Chicago Innovation Mentors (CIM). Jerzy speaks Polish and Spanish.
Navigating Clinical Strategies for Combination Products with Investigational Devices
Friday, November 14, 2025
1:15 PM - 2:30 PM East Coast USA Time