EU MDR Regulatory Consultant

Job Summary

Serving as the Regulatory Affairs core team representative for EU MDR compliance, the full-time EU MDR Regulatory Consultant will execute regulatory activities for medical products, including technical documentation and change assessments, in a remote capacity.

Key responsibilities

• Execute EU MDR regulatory activities for product changes, technical documentation, submissions, and lifecycle maintenance
• Assess product changes for EU MDR impact, identifying compliance gaps and risks, and escalate issues as appropriate
• Prepare, review, and maintain EU MDR technical documentation and regulatory deliverables while collaborating with cross-functional teams

Required qualifications

• Bachelor's degree or equivalent in a scientific, engineering, regulatory, or related discipline
• Minimum 5 years of Regulatory Affairs or related medical device experience
• Strong hands-on EU Medical Device Regulation (EU MDR) regulatory expertise
• Experience with EU MDR technical documentation, change assessments, and Notified Body interactions
• Regulatory experience with Connected Monitoring and/or Respiratory Health medical products, including software