Clinical And Regulatory Affairs Consultant

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 and Regulatory Affairs Consultant!

(2 years mission-  min 20 hours per week)

Your main responsibilities will be:

• Managing clinical evaluations by planning and leading the process with third party clinical evaluation authors
• Developing a streamlined and consistent process.
• Other tasks include supporting clinical submissions to regulatory bodies, clinical regulatory strategy development; developing Post Market Clinical Follow-up plans and Summary of Safety and Clinical Performance (SSCPs) documents.

Your profile:

• Over 5 years of experience in clinical evaluation writing, ideally in the orthopedic field, focusing on spine surgery
• Qualification in a clinical or medical field, with.
• Advanced knowledge of the EU 2017/745 MDR regulatory framework
• Fluent in French and English.