Job Description

Job Description

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 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 You’ll 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
• Bachelor’s 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

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