Medical Writer – Clinical Evaluation, Medical Devices
Excelya
full-time
Posted on:
Location Type: Hybrid
Location: Lyon • 🇫🇷 France
Visit company websiteJob Level
JuniorMid-Level
About the role
- 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
- 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
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical evaluation reportsliterature searchescritical analysisclinical evaluation planspost-market clinical follow-uprisk analysesregulatory requirementsMEDDEV 2.7/1 rev.4EU MDR 2017/745
Soft skills
writing skillsediting skillsattention to detailcommunication skills