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.