Regulatory Affairs Specialist

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.

For immediate consideration, apply today or contact Scot Widjaja at (213) 262-2064.