Lead Regulatory Affairs Engineer

Job Summary

A company is looking for a Lead Regulatory Affairs Engineer.

Key Responsibilities

• Author technical documentation for regulatory submissions, focusing on European MDR
• Develop strategies for compliance with regulatory standards and maintain technical documentation
• Support regulatory audits and manage aspects of Post Market Surveillance

Required Qualifications

• Bachelor's Degree in a technical, business, or engineering field required
• 6-10 years of experience in regulatory affairs or product development in a medical device company
• Significant experience in writing full technical documentation files
• Knowledge of EU Medical Device Regulation and related compliance requirements
• Regulatory Affairs Certification (RAC) preferred