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. Accountabilities: - Develop and implement global regulatory strategies that support medical device product development, commercialization, market access, and lifecycle management. - Provide regulatory leadership and guidance throughout all stages of product design, development, verification, validation, product release, and post-market support. - Advise executive leadership on regulatory risks, business opportunities, emerging requirements, and their potential impact on organizational objectives. - Lead, mentor, and develop Regulatory Affairs team members, fostering technical expertise and effective collaboration. - Oversee the preparation, review, submission, and ongoing maintenance of regulatory filings and documentation across international markets. - Ensure timely maintenance and renewal of product registrations, licenses, and approvals in all applicable markets.

- Manage communications and relationships with regulatory authorities, notified bodies, distributors, and international representatives. - Ensure regulatory requirements are effectively integrated into the Quality Management System (QMS) and aligned with applicable standards. - Participate in internal and external audits, supplier audits, and regulatory inspections, supporting readiness and timely resolution of findings. - Collaborate with Engineering and Product Development teams to incorporate regulatory requirements into product designs and development activities. - Review and approve product claims, labeling, instructions for use (IFUs), advertising, promotional materials, and marketing communications to ensure regulatory compliance. - Participate in design reviews and product development projects as a key regulatory stakeholder. - Monitor emerging regulations, guidance documents, international standards, and industry best practices to anticipate changes and maintain ongoing compliance. Requirements: - Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline. - Master's degree in a relevant field is preferred. - At least 7–10 years of professional experience in medical device regulatory affairs. - Minimum of 3 years of leadership, supervisory, or project management experience. - Demonstrated experience preparing and managing FDA regulatory submissions, international registrations, and global market access activities. - Strong knowledge of regulatory frameworks and requirements across the FDA, European Medical Device Regulation (MDR), United Kingdom, Canada, and Medical Device Single Audit Program (MDSAP). - Experience working with Class II and/or Class III medical devices is preferred.