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.
Key Responsibilities
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
What We Offer
Youll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working toward a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core valuesTrust, Quality, Passion, Flexibility, and Sustainabilityguide our decisions at every level of the organization. These values help us attract and retain outstanding talent, foster high employee engagement, and create a culture of mutual respect and collaboration. Together we make a difference.