Regulatory Affairs Operations Manager

Job Summary

Managing regulatory operations, the full-time salaried Regulatory Affairs Operations Manager will oversee Global Unique Device Identification (UDI), FDA Establishment Registrations, and US State Licenses while providing guidance to cross-functional teams and ensuring compliance with regulatory standards.

Key responsibilities:

• Provide guidance for updates to FURLS to maintain accuracy of FDA Establishment Registrations and Device Listings
• Manage US State licenses for all medical device activities and support global UDI initiatives
• Identify new regulations impacting Quality Management Systems and communicate necessary changes for implementation

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
• Strong results orientation and analytical skills