FDA Regulatory Affairs Specialist

Job Summary

To support the regulatory compliance of in vitro diagnostic products, the full-time FDA Regulatory Affairs Specialist will prepare and maintain U.S. FDA regulatory submissions, manage product registrations, and ensure compliance with applicable regulations in a fully remote capacity.

Key responsibilities

• Determine regulatory pathways and prepare submissions, including 510(k) and PMA, for product market entry
• Monitor and maintain the regulatory status of marketed products, ensuring ongoing compliance and availability
• Review labeling and promotional materials for compliance with FDA regulations and maintain inspection-ready regulatory records

Required qualifications

• Bachelor's degree in a related discipline with 3+ years of experience in U.S. regulatory submissions
• Experience with at least one successful 510(k), De Novo, or Pre Market Approval request to the FDA
• Broad knowledge of U.S. FDA medical device regulations and ISO 13485 standards
• Effective technical writing skills and the ability to organize information clearly
• Strong organizational skills with the ability to manage multiple tasks in a fast-paced environment