Poste
Missions
Affiliated to the Paris site, support the Associate Director in charge of Quality Assurance and Strategy for the Medical Devices portfolio in coordinating and implementing the regulatory strategy for Medtech partnerships and activities related to MDs, MD-IVDs, and combination products.
Main Activities
Regulatory Affairs
Regulatory Strategy: Compile all data necessary for defining and/or refining regulatory strategies.Regulatory Documentation: Establish and/or review and/or update regulatory documentation, particularly related to clinical studies.Regulatory Submissions: Advise on and/or manage regulatory submissions, ensuring compliance with the requirements of the relevant authorities.Interactions with Authorities: Support the preparation, conduct and follow-up of interactions with regulatory authorities / notified bodies.Regulatory Watch: Monit...