Medical Writer - Clinical Evaluation for Medical Devices

Excelya; Lyon; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A growing healthcare company in Lyon is looking for a Medical Writer focused on Clinical Evaluation for Medical Devices. This role involves developing clinical evaluation documentation and requires at least 2 years of experience in writing Clinical Evaluation Reports. Candidates should possess a university degree in life sciences or biomedical engineering, with strong writing and analytical skills. Join a dynamic team that values collaboration and pushes the boundaries of healthcare excellence.

Qualifications

• Minimum 2 years of experience in writing Clinical Evaluation Reports under MEDDEV or EU MDR.
• Strong attention to detail and quality-oriented.
• Proficient in English, both written and spoken.

Responsabilités

• Develop and maintain clinical evaluation documentation.
• Perform systematic literature searches and critical analyses.
• Write Clinical Evaluation Plans and Reports.

Connaissances

Clinical research processes understanding

Excellent writing skills

Literature search proficiency

Formation

University degree in life sciences or biomedical engineering

Description du poste

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Overview

We are currently looking for a Medical Writer focused on Clinical Evaluation for Medical Devices to join our growing team. This position will provide you with the opportunity to work on exciting projects that contribute to the advancement of medical technologies.

Reporting

Reporting to the Head of Clinical Evaluation & Medical Writing, your primary mission will be to develop and maintain clinical evaluation documentation for implantable medical devices (Class IIb and III).

Main Responsibilities

• Perform systematic scientific literature searches, selection, and critical analysis
• Build comprehensive state-of-the-art summaries on pathologies, standard of care, and available therapies
• Contribute to CE marking submissions and renewals
• Write and/or update Clinical Evaluation Plans and Reports in line with MEDDEV 2.7/1 rev.4 and EU MDR 2017/745
• Support Post-Market Clinical Follow-up activities (PMCF Plans & Reports)
• Work closely with Regulatory Affairs, R&D and Engineering teams (risk analyses, responses to Notified Bodies, clinical justifications, etc.)
• Support dissemination of scientific knowledge and product-specific data

Requirements

About You

We seek motivated and skilled individuals who are ready to contribute to our mission with a strong focus on quality and accuracy:

• Education: University degree in life sciences, biomedical engineering, or a related field.
• Experience: A minimum of 2 years of experience in writing Clinical Evaluation Reports under MEDDEV or EU MDR
• Skills: Strong understanding of clinical research processes and regulatory requirements for medical devices.
• Excellent writing and editing skills with attention to detail.
• Proficient in conducting literature searches and analyses.
• Languages: Proficient in English (written and spoken)

Benefits

Why Join Us?

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

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.