Consultant Clinical Affairs
Qserve GroupGelderland, Netherlands
Posted December 31, 2025
Full Time
About the Company
Qserve Group is a global partner for regulatory, clinical, and quality compliance services for medical devices and in vitro diagnostics, as well as a CRO for medical device clinical trials.
Job Description
We are seeking a Consultant Clinical Affairs with strong medical writing skills and expertise in systematic literature searching and clinical evaluation of medical devices. The role will support clients in navigating complex regulatory landscapes and ensuring compliance and market access for multiple solutions in healthcare.
Requirements
- Technical or scientific degree (BSc, MSc, or Ph.D.) in biomedical engineering, biomedical science, biology, or similar.
- At least 4 years of experience in clinical evaluation of medical devices (EU-MDD and EU-MDR) in industry, consultancy, or Notified Body roles.
- Hands-on experience with systematic literature search design and appraisal of medical devices.
- Familiarity with ISO 13485 and medical device Quality Management Systems.
