Regulatory Affairs Specialist

Job Summary

To support regulatory project execution, the full-time Regulatory Affairs Specialist will manage the preparation of documents for regulatory submissions and maintain awareness of regulatory requirements while working remotely.

Key responsibilities

• Support regulatory project plan execution and maintain regulatory files
• Compile and prepare responses to regulatory authority inquiries and edit regulatory documentation
• Participate in project teams and assist in the preparation and review of labeling and SOPs

Required qualifications

• Bachelor's degree in a relevant scientific discipline
• Familiarity with US and OUS device regulations, including EU device regulations
• Experience in regulatory affairs strategy development and working with cross-functional teams
• Experience interacting with external regulators such as the FDA and TUV
• Minimum of 4 years of experience working with medical devices