The Regulatory Affairs Coordinator III independently supports and executes regulatory activities for U.S. Class II and EU Class II & Class III medical devices across the product lifecycle. This role prepares and maintains regulatory submissions and technical documentation, ensures ongoing compliance with FDA and EU MDR requirements, and serves as a regulatory partner to cross-functional teams. This role (Coordinator III) is hybrid (remote/in-office) and works with limited supervision.
Education

• Bachelor s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field

Experience

• 5-7 years of Regulatory Affairs experience in the medical device industry


• Direct experience supporting Class II medical devices in the U.S. and Class II and/or Class III medical devices EU


• Hands on involvement with EU MDR technical files