Senior Regulatory Affairs Specialist

Job Summary

Supporting regulatory activities for a Legal Manufacturer address change, the contract Senior Regulatory Affairs Specialist will lead regulatory actions, update documentation, and ensure compliance with global requirements while working remotely.

Key responsibilities

• Lead regulatory actions for a Legal Manufacturer address change across global markets
• Update and maintain regulatory documentation, including technical files and product registrations
• Prepare and submit regulatory notifications and updates to health authorities as required

Required qualifications

• Bachelor's degree in a scientific, engineering, or regulatory discipline (advanced degree preferred)
• 5+ years of experience in Regulatory Affairs within the medical device or related regulated industry
• Strong understanding of FDA, EU MDR, and global regulatory requirements
• Experience with regulatory submissions and change management
• Ability to work independently in a remote environment and manage multiple priorities