Clinical Evaluation and Regulatory Affairs Specialist

For one of our clients, an international player experiencing strong growth
Regulatory and Clinical Affairs Specialist
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 specialized 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 regulation MDR 2017/745.
Supervise and guarantee the quality of the entire clinical evaluation package (LSPR, CEP, CER).
Coordinate and supervise external authors in charge of drafting CERs.
Verify the consistency and integration of different sources of evidence: IFU, risk management files, PMS data, trials and tests, labeling, complaints, vigilance, and scientific literature.
Ensure the alignment of clinical data within all regulatory documentation.
Train and support external providers involved in drafting CERs.
Clarify expectations, the structure of clinical evidence, and internal processes in order to optimize collaboration and the management of a large volume of documentation.
Prepare and update the clinical documentation necessary for regulatory submissions, notably:
PMCF plans and reports
SSCP
Clinical sections of the technical documentation
Contribute to the continuous improvement of templates, processes, and workflows to ensure documentary consistency.
Provide support to the Regulatory Affairs teams during interactions with notified bodies.
Profile sought
Expertise 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 regulation MDR 2017/745.
Ability to analyze and structure large volumes of scientific and clinical data.
Analytical mind, rigor, and ability to coordinate multiple stakeholders.
Fluent French and English, both spoken and written. jpid6a72bc5jm jpit0937jm jpiy26jm