Senior Regulatory Affairs Manager

Job Summary

A company is looking for a Senior Manager of Regulatory Affairs.

Key Responsibilities

• Own the end-to-end lifecycle of FDA premarket applications, focusing on 510(k) submissions
• Maintain compliance across various jurisdictions, including FDA and CMS
• Serve as the primary regulatory contact for agency audits and inspections

Required Qualifications

• 12+ years of experience in Regulatory Affairs, particularly in the Medical Device industry
• Proven track record with successful FDA 510(k) clearances, especially for IVDs
• Extensive knowledge of health regulation, including FDA, DEA, CMS/CLIA, and FTC
• Advanced degree in Regulatory Affairs, PhD, JD, or equivalent experience
• Ability to thrive in fast-paced, high-growth environments