Medical Writer - Clinical Evaluation For Medical Devices H/F - 69

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

Join Excelya, whereAudacity, Care, and Energydefine 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.

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 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