Regulatory Affairs Specialist

Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, you'll play a critical part in bringing transformative orthopedic technologies to market, helping surgeons deliver better outcomes, faster recovery times, and higher quality of life for those with musculoskeletal conditions.Why You Should ApplyJoin a company that thrives on innovation and real-world patient impactCollaborate with cross-functional experts in a fast-paced, clinical product environmentPlay a hands-on role in FDA submissions for breakthrough Class II and III medical devicesEnjoy a culture that blends urgency, teamwork, and a passion for clinical resultsWhat You'll Be DoingDrafting and submitting 510(k), IDE, and PMA regulatory submissionsPartnering with Product Development teams to align on regulatory strategyReviewing clinical data and collaborating with internal teams to support submissionsMaintaining PMA records, preparing supplements and annual reportsTraining team members and contributing to SOP development and regulatory complianceAbout YouBe able to do the job as describedBachelor's in health/science-related field; Engineering degree is a plus2-5 years' experience in Regulatory Affairs in the medical device industryKnowledge of orthopedic medical devices is highly preferredComfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)Strong documentation, review, and cross-functional communication skills

Created: 2025-06-09