Regulatory Affairs Manager-Medical Devices

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.

• 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.

• Previous experience in FDA-regulated environments and organizations operating under ISO 13485-certified Quality Management Systems is required.

• Strong understanding of medical device development processes, regulatory documentation, product lifecycle management, and post-market compliance.

• Proven ability to develop and execute regulatory strategies while balancing business objectives and compliance requirements.

• Excellent leadership, communication, and stakeholder management skills, with the ability to influence cross-functional teams and advise senior management.

• Strong analytical skills, attention to detail, and the ability to manage multiple regulatory projects and priorities effectively.

• Preferred certifications: Regulatory Affairs Certification (RAC), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), or ISO 13485 Lead Auditor Certification.

• Ability to work remotely while remaining available for occasional onsite visits in Maine or Pennsylvania.