Responsable des Affaires Réglementaires H/F

This position involves leading the execution of regulatory strategies for a portfolio of innovative medical devices, with a specific focus on Software as a Medical Device. The role reports to the Vice President of Regulatory Affairs and requires close collaboration with clinical, quality, research and development, product, and marketing teams. Day-to-day duties include defining intended use, indications, labeling, and associated documentation while supporting global regulatory classification strategies. You will manage the preparation, submission, and maintenance of regulatory dossiers, including FDA submissions and CE marking activities. The job also requires reviewing and approving key technical documents such as product specifications, risk management files, verification and validation records, and user documentation. Additionally, you must assess the regulatory impact of product and process changes, monitor evolving regulatory policies, and maintain data in systems like the FDA Device List, EUDAMED, and ClinicalTrials.gov. The role involves acting as a Responsible Person for PRRC compliance. The provided text does not specify required skills, tools, experience levels, qualifications, or language requirements. It also does not state the employment type or who the role specifically suits. The working arrangement is remote.