Clincal Evaluation Manager Medical Devices

About the Job

At Excelya, we embody the values of Audacity, Care, and Energy as we strive to develop innovative solutions in a fast-paced, collaborative environment. We are seeking a skilled Medical Writer to join our dedicated team. This role offers the opportunity to create impactful documentation that plays a crucial role in the medical research and development process.

As a Medical Writer, you will be responsible for developing high-quality, scientifically accurate, and compliant documents to support clinical studies and regulatory submissions, ensuring that the information is clear, concise, and accessible to a wide range of stakeholders.

Main Responsibilities:

• Perform scientific literature surveillance in bibliographic databases, including search strategy development, publication selection, and critical analysis
• Compile relevant information into structured state-of-the-art sections covering the targeted pathology, therapeutic alternatives, and standard of care
• Contribute to CE marking submissions and renewals
• Draft and/or update Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), including critical appraisal of relevant clinical data in accordance with applicable guidelines
• Support Post-Market Clinical Follow-up activities (PMCF Plans and PMCF Reports)
• Collaborate closely with internal teams such as Regulatory Affairs and R&D/Engineering (clinical justifications to Notified Bodies, risk analyses, co-authoring of technical documentation)
• Contribute to the scientific valorization and dissemination of knowledge related to company products

Requirements:
About You

We are looking for passionate professionals who are committed to delivering excellence and have a strong aptitude for scientific communication:

• Education: Degree in life sciences (MSc, Engineering degree, or equivalent), ideally complemented by specialization in clinical evaluation
• Experience: Experience in drafting Clinical Evaluation Reports under MEDDEV 2.7/1 rev.4 or EU Medical Device Regulation (EU MDR 2017/745)
• Skills: Strong understanding of clinical research processes and regulatory requirements.
• Excellent writing, editing, and organizational skills with meticulous attention to detail.
• Proficiency in Microsoft Office Suite and literature databases.
• Languages: Proficient in English (written and spoken); additional languages are a plus.

Benefits:
Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.