About

Jerzy Wojcik is Vice President of Regulatory and Quality Services at EdgeOne Medical, 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.

Mr Wojcik also has expertise in US distribution and dispensing compliance, as well as regulatory surveillance for drugs, biologics and devices. In addition to regulatory responsibilities, Mr Wojcik also helps to develop
and implement quality systems and various process quality compliance initiatives. He holds a Bachelor of Science in Biology, Medical Technology and Cytotechnology from Augustana College (Rock Island, IL, US), and was an Adjunct Professor in the School of Law at Northwestern University (Evanston, IL, US). He is a member of Regulatory Affairs Professional Society and volunteers with Chicago Innovation Mentors. Mr Wojcik speaks Polish and Spanish.