Clinical Regulatory Affairs Manager

Do you want to work for an innovative specialist spinal implant company and play a pivotal role in advancing medical research?

If yes, come to join our clinical studies team as Clinical Regulatory Affairs  Manager

(fixed term contract- until the end of 2026)

Your main responsibilities will be:

• Managing Clinical Evaluation Reports for implantable medical devices.


• Supporting updates of annual PSURs, including annual PMCF plans, PMCF reports, user surveys, literature reviews.


• Supporting annual updates of SSCPs.


• Additionally, supporting process improvement initiatives associated with Clinical Evaluations, PMCF reports, User Surveys, and SSCPs.

Your profile:

• Over 5 years of experience in clinical evaluation writing, ideally in implantable medical devices, spine surgery: evaluation Reports , PMCF reports, SSCPs


• Expertise in literature reviews

• Recognized qualification in a clinical or medical field


• Advanced knowledge of the EU 2017/745 MDR regulatory framework


• Fluent in French and English, both are daily working language


• Strong organizational and interpersonal skills