Regulatory Affairs Specialist

Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, youll 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 Apply Join a company that thrives on innovation and real-world patient impact Collaborate with cross-functional experts in a fast-paced, clinical product environment Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices Enjoy a culture that blends urgency, teamwork, and a passion for clinical results What Youll Be Doing Drafting and submitting 510(k), IDE, and PMA regulatory submissions Partnering with Product Development teams to align on regulatory strategy Reviewing clinical data and collaborating with internal teams to support submissions Maintaining PMA records, preparing supplements and annual reports Training team members and contributing to SOP development and regulatory compliance About You Be able to do the job as described Bachelors in health/science-related field; Engineering degree is a plus 2-5 years experience in Regulatory Affairs in the medical device industry Knowledge of orthopedic medical devices is highly preferred Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA) Strong documentation, review, and cross-functional communication skills