Regulatory Affairs Principal Specialist

Job Summary

Managing regulatory activities for a portfolio of medical device products, the full-time Regulatory Affairs Principal Specialist will develop regulatory strategies, assess product changes, and support submissions to ensure compliance and market access across the U.S., EU, and other global markets.

Key responsibilities

• Manage regulatory approvals, registrations, and change assessments for medical device products
• Develop regulatory strategies and submission plans for product and process changes
• Prepare and submit U.S. regulatory filings, including 510(k) submissions and responses to FDA requests

Required qualifications

• Bachelor's degree in a scientific or engineering discipline
• 5 years of regulatory experience in the medical device industry
• Experience with FDA change assessment guidance and EU MDR technical documentation
• Successful preparation and submission of 510(k)s
• Familiarity with global registrations beyond the U.S. and EU