Regulatory Affairs Engineer

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 manage post-market surveillance activities Required Qualifications Bachelor's Degree or equivalent education and experience; M.S. or M.B.A. preferred 1+ year of experience in a regulated industry, preferably in medical devices Knowledge of regulatory guidelines, standards, and submission types Regulatory Affairs Certification (RAC) is a plus Technical writing experience is strongly preferred

Apr 10, 2025 - 18:50

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 manage post-market surveillance activities Required Qualifications Bachelor's Degree or equivalent education and experience; M.S. or M.B.A. preferred 1+ year of experience in a regulated industry, preferably in medical devices Knowledge of regulatory guidelines, standards, and submission types Regulatory Affairs Certification (RAC) is a plus Technical writing experience is strongly preferred