Regulatory Affairs Associate

Job Summary

To support regulatory project plan execution, the full-time Regulatory Affairs Associate will be responsible for the global coordination and preparation of documents for regulatory submissions while working remotely.

Key responsibilities

• Compile and prepare regulatory documents for submission and respond to inquiries from regulatory authorities
• Review and evaluate technical and scientific data required for global product submissions
• Maintain regulatory files and ensure compliance with evolving regulatory requirements

Required qualifications

• Bachelor's degree in a relevant scientific discipline or equivalent experience
• Minimum of 5 years of experience with USA and OUS device regulations, including EU device regulations
• Experience in regulatory strategy development and working with cross-functional teams
• Familiarity with regulatory documentation and submission processes
• Knowledge of FDA and other regulatory authority interactions