Clinical Evaluation Expert - Remote

Overview

TFS HealthScience is supporting an Italy-based medical device manufacturer in the search for a Clinical Evaluation Expert with solid experience in EU MDR compliance for Class III orthopedic devices. This is a senior-level consulting assignment ideal for an experienced professional confident in working independently within a remote, fast-paced environment. Remote work is acceptable.

In Short

• Lead or support the review, update, and maintenance of Clinical Evaluation Reports (CERs)
• Ensure full compliance with EU MDR, MEDDEV 2.7/1 Rev. 4, and related regulatory standards
• Provide expert input on clinical evaluation strategy for Class III orthopedic devices
• Collaborate with a compact and experienced project team
• Contribute to the continuous improvement of evaluation processes and documentation

Requirements

• Demonstrated experience with clinical evaluations under MDR, especially for Class III devices
• Strong regulatory knowledge including EU MDR and MEDDEV 2.7/1 Rev. 4
• Experience with orthopedic medical devices
• Excellent scientific writing and analytical skills
• Fluency in English (Italian is a plus)
• 100% FTE

Benefits

• You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.