Regulatory Affairs Specialist

Job Summary

Seeking a full-time Staff Regulatory Affairs Specialist, this role offers the flexibility to work remotely or onsite, focusing on managing regulatory compliance and post-market activities for advanced orthopedic technologies across U.S. and global markets.

Key responsibilities

• Develop and execute regulatory strategies for post-market products to maintain market access globally
• Author and submit regulatory documents, including FDA submissions and international dossiers
• Partner with cross-functional teams to support regulatory agency interactions and ensure compliance with evolving regulations

Required qualifications

• Bachelor's degree in engineering, science, or a related field
• Minimum 4 years of experience in an FDA-regulated industry
• Minimum 2 years of experience in regulatory affairs
• Experience supporting regulatory submissions or compliance activities
• Knowledge of U.S. and international medical device regulations