Clinical Evaluation Expert

TFS HealthScience; Roma; Remoto; EUR 50.000 - 90.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Evaluation Expert to support a medical device manufacturer. This senior-level consulting role offers the flexibility of remote work and requires a professional with solid experience in EU MDR compliance for Class III orthopedic devices. You will lead the review of Clinical Evaluation Reports and ensure adherence to regulatory standards while collaborating with an experienced team. Join a company that values innovation and makes a real difference in patient lives, contributing to a healthier future through tailored clinical research services across various therapeutic areas.

Competenze

• Solid experience in EU MDR compliance for Class III orthopedic devices.
• Strong regulatory knowledge and analytical skills.

Mansioni

• Lead the review and maintenance of Clinical Evaluation Reports (CERs).
• Ensure compliance with EU MDR and related standards.

Conoscenze

Clinical evaluations under MDR

Regulatory knowledge (EU MDR, MEDDEV 2.7/1 Rev. 4)

Scientific writing

Analytical skills

Experience with orthopedic medical devices

Fluency in English

Descrizione del lavoro

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

1. Lead or support the review, update, and maintenance of Clinical Evaluation Reports (CERs).
2. Ensure full compliance with EU MDR, MEDDEV 2.7/1 Rev. 4, and related regulatory standards.
3. Provide expert input on clinical evaluation strategy for Class III orthopedic devices.
4. Collaborate with a compact and experienced project team.
5. 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.