Regulatory Affairs Specialist

Responsibilities

• Act as a lead regulatory representative on core product development teams, communicating regulatory requirements and impacts to project teams and providing input related to FDA and international product registrations and licensing requirements.
• Develop global regulatory strategies for new and modified products.
• Support the monitoring and interpretation of current and new regulatory requirements and international standards for the U.S. and Rest of World (RoW).
• Lead the regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR).
• Independently identify and solve regulatory and compliance issues, escalating to senior management as necessary.
• Provide effective communication and prompt responses to internal customers.
• Drive continuous improvement in internal processes and customer satisfaction.
• Identify, develop, and mentor high‑performing regulatory talent.
• Ensure US FDA Quality Management System (QMSR) requirements are followed and executed consistently from an RA perspective.
• Execute US FDA 510(k) and Technical File creation and remediation, collaborating with cross‑functional teams for required content.
• Draft and execute comprehensive regulatory impact assessments for design control changes to existing products.
• Perform other duties and assignments as required.

• Bachelor’s Degree in a scientific discipline such as Chemistry, Life Sciences, Biology, or equivalent vocational qualifications.
• 8 years of experience with a B.S. OR 6 years of experience with an M.S. in regulatory submissions for medical devices.
• Experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
• Ability to work effectively on project teams.
• Capacity to manage multiple competing priorities and programs with minimal oversight.
• M.S. or Ph.D. in a technical area.
• Experience working with both Class II and Class III medical devices.
• Certification is a plus (e.g., RAC from the Regulatory Affairs Professionals Society).
• Strong attention‑to‑detail, strong written, verbal, presentation, and organizational skills.
• Strong analytical and problem‑solving skills.
• Working knowledge of relevant ISO and EN standards.
• Strong knowledge of regulatory requirements for the U.S., EU (EU MDR), and other international geographies.
• Ability to identify risk areas and appropriately raise issues.