Suggestions
Jerzy W.
Providing strategic assessment and advice for quality and regulatory aspects of combo product and medical device development.
Jerzy Wojcik is the Senior Director of Regulatory Affairs and Quality Assurance at EdgeOne Medical, where he has over 25 years of experience in the medical device industry. His career includes significant roles at well-known companies such as Baxter Healthcare, Abbott Laboratories, and Deloitte, focusing on regulatory and quality management for medical devices and combination products.14
Professional Background
- Experience: Jerzy has extensive expertise in regulatory activities across all stages of product development, particularly for Class I, II, and III medical devices in both the U.S. and EU markets. His work includes compliance with regulations for drug, biologics, and devices.12
- Education: He holds a Bachelor of Science degree in Biology, Medical Technology, and Cytotechnology from Augustana College in Illinois.12
- Languages: Jerzy is fluent in Polish and Spanish.1
Additional Roles
In addition to his role at EdgeOne Medical, Jerzy has served as an Adjunct Professor at Northwestern University's School of Law and is actively involved with the Regulatory Affairs Professional Society (RAPS) and Chicago Innovation Mentors (CIM).14
His strategic insights into quality and regulatory aspects have made him a valuable asset in the development of innovative medical solutions.3
