Offer summary

Qualifications:

Solid experience in EU MDR compliance for Class III orthopedic devices., Strong regulatory knowledge including EU MDR and MEDDEV 2.7/1 Rev. 4., Excellent scientific writing and analytical skills., Fluency in English; Italian is a plus..

Key responsibilities:

Lead or support the review, update, and maintenance of Clinical Evaluation Reports (CERs).

Ensure full compliance with EU MDR and related regulatory standards.

Provide expert input on clinical evaluation strategy for Class III orthopedic devices.

Collaborate with a compact and experienced project team.

Job description

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
You’ll 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 values—Trust, Quality, Passion, Flexibility, and Sustainability—guide 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.

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