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 

       We look forward to receiving your application at

https://spineart.bamboohr.com/careers/81?source=aWQ9MTE%3D