Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist responsible for securing timely product clearances, preparing regulatory submission documents, and providing strategic guidance on clinical studies and evaluations.

Requirements

• 5+ years of experience in medical device regulatory affairs
• 510(k) and EU MDR Technical Documentation authoring experience
• Strong understanding of relevant regulations and standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other applicable regulations and standards related to software medical devices)
• RAPS certification
• Bachelor's/Master's Degree in a science, engineering, or health-related discipline

Benefits

• PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement