Regulatory Affairs Operations Manager

Job Summary

Managing regulatory operations, the full-time salaried Regulatory Affairs Operations Manager will lead a team focused on Global Unique Device Identification (UDI), FDA Establishment Registrations, and US State Licenses while ensuring compliance with regulatory requirements.

Key responsibilities:

• Provide guidance for updates to FDA Establishment Registrations and Device Listings, including annual re-registration submissions
• Support cross-functional teams with regulatory guidance related to global UDIs
• Oversee management of US State licenses for medical device activities and communicate new regulations impacting quality management systems

Required qualifications:

• 5+ years of experience in regulatory affairs, preferably in the medical device industry
• Experience leading regulatory operations for medical devices
• Knowledge of FDA regulations and international standards (e.g., ISO 13485)
• Bachelor's degree in a relevant field such as life sciences or regulatory affairs