Regulatory & Clinical Specialist

Job Summary

Supporting clinical evaluation activities, the full-time Regulatory & Clinical Specialist will manage the preparation of clinical evaluation plans and reports, conduct literature searches, and oversee regulatory submissions for active implantable medical devices in a remote capacity.

Key responsibilities

• Author and update clinical evaluation plans (CEP) and reports (CER) in compliance with EU MDR requirements
• Conduct systematic literature searches and analyze data related to safety and performance of medical devices
• Prepare regulatory submissions and interface with regulatory agencies on assigned projects

Required qualifications

• Master's degree in biomedical engineering, science, or equivalent technical discipline with at least 5 years of related experience, or a Ph.D. with at least 3 years of experience
• Experience in writing Clinical Evaluation Plans and Reports to support EU MDD and MDR requirements
• Demonstrated experience in regulatory submissions, including FDA PMA applications and IDE Progress Reports
• Familiarity with Class III active-implantable medical devices preferred
• Strong understanding of EU and FDA regulations and guidance documents