Regulatory Affairs Engineer

Job Summary

A company is looking for a Regulatory Affairs Engineer.

Key Responsibilities

• Prepare and maintain regulatory submissions for domestic and international markets
• Review and approve document changes to ensure regulatory compliance throughout product lifecycle
• Support regulatory audits and assist with post-market surveillance activities

Required Qualifications

• Bachelor's Degree or equivalent education and experience; M.S. or M.B.A. preferred
• Regulatory Affairs Certification (RAC) is a plus
• 1+ years of experience in regulatory affairs or product development in a regulated industry
• Knowledge of regulatory guidelines, policies, and standards relevant to medical devices
• Technical writing experience strongly preferred