Regulatory Affairs Manager-Medical Devices

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Manager – Medical Devices based in the United States. As a Regulatory Affairs Manager, you will lead global regulatory strategies and ensure compliance across the full lifecycle of medical devices. You will play a key role in supporting product development, commercialization, international market access, and ongoing regulatory activities. Working closely with Engineering, Quality, Product Development, and executive leadership, you will ensure regulatory requirements are integrated into business and product decisions. You will oversee regulatory submissions, product registrations, and interactions with regulatory authorities and international stakeholders. This position also offers the opportunity to lead and develop regulatory professionals while strengthening quality and compliance practices across the organization. You will contribute to the development of innovative medical technologies within an established, collaborative, and innovation-driven environment. The role is remote, with occasional onsite visits required to locations in Maine or Pennsylvania.