Mission :

• Lead and ensure the quality of the full Clinical Evaluation package (LSPR, CEP, CER):

Oversee external authors and validate their work, ensuring all evidence sources (IFUs, risk files, PMS data, testing, labeling, complaints, vigilance, literature) are correctly interpreted, updated in the relevant sections, and fully aligned across the Clinical Evaluation. This is the core and most time‑critical part of the role.

• Onboard and guide external CER vendors:

Provide initial training and ongoing support so vendors understand Company expectations, evidence structure, and how to work efficiently with the high volume of supporting documents.

• Deliver submission‑ready clinical documentation and improve processes:

Prepare PMCF Plans/Reports, SSCPs, and clinical sections of Technical Documentation, while refining templates and workflows to increase consistency and support RA during notified body interactions.