My client is a well-established, rapidly growing medical device manufacturer specializing in sterile surgical products used in hospitals, surgical centers, and outpatient facilities around the world.
We’re looking for a Regulatory Affairs Specialist to support global compliance efforts and quality system initiatives. This role is ideal for someone who thrives in a fast-paced, highly regulated environment and enjoys working cross-functionally across Quality, Operations, and Product teams.
What You’ll Do:
- Lead document control and CAPA processes to ensure QMS compliance (ISO 13485/FDA/EU MDR)
- Provide regulatory support across U.S. and international markets
- Collaborate with cross-functional teams to interpret and apply regulatory standards
- Coordinate with global Authorized Reps and support shipping authorization documentation
- Analyze and present quality/regulatory data to internal stakeholders
- Assist with audit preparation and improvement initiatives
What We’re Looking For:
- 2+ years of regulatory affairs or quality experience in the medical device industry
- Familiarity with ISO 13485, 21 CFR 800+, and EU MDR requirements
- Experience supporting 510(k), IDE, or PMA submissions is a plus
- RAPS (RAC/RCC) or ASQ (CQE/CQA) certification preferred
- Strong analytical and communication skills
This is a high-impact opportunity to support global regulatory strategy while directly contributing to continuous improvement initiatives in a collaborative, quality-driven environment.