For one of our clients, an international player experiencing strong growth in the field of medical devices, we are looking for a Clinical Evaluation and Regulatory Affairs Specialist.

Clinical Evaluation and Regulatory Affairs Specialist

Main missions:

Within an international environment specialised in medical devices, you are responsible for the quality, consistency and compliance of all clinical evaluation documentation, in accordance with the requirements of the European MDR Regulation 2017/745.

• Supervise and ensure the quality of the entire clinical evaluation package (LSPR, CEP, CER).
• Coordinate and manage the external authors responsible for drafting the CERs.
• Verify the consistency and integration of the various sources of evidence: IFU, risk management files, PMS data, trials and tests, labelling, complaints, vigilance and scientific literature.
• Ensure the alignment of clinical data within all regulatory documentation.
• Train and support the external providers involved in drafting the CERs.
• Clarify expectations, the structure of clinical evidence and internal processes to optimise collaboration and management of a large volume of documentation.
• Prepare and update the clinical documentation necessary for regulatory submissions, including:
• PMCF plans and reports
• SSCP
• Clinical sections of the technical documentation

• Contribute to the continuous improvement of templates, processes and workflows to ensure document consistency.
• Provide support to the Regulatory Affairs teams during interactions with notified bodies.

Profile sought

• Minimum 5 years of experience in writing and managing clinical evaluations in the field of medical devices.
• Training in a clinical, medical or scientific field.
• Excellent knowledge of the European MDR Regulation 2017/745.
• Ability to analyse and structure large volumes of scientific and clinical data.
• Analytical mindset, rigour and ability to coordinate multiple stakeholders.
• Fluent French and English, both spoken and written.