Regulatory & Clinical Specialist

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