Regulatory Affairs Officer 610

In the context of a new project, we are looking for a Regulatory Affairs Officer in medical devises to join our teams in Paris.

Responsibilities

Write the dossiers and coordinate with the different contributors (R&D, Production, QA, Clinical,..)
Ensure that the constitution of the registration dossiers is in accordance with the new European regulation (2017/745) or specific requirements in another zone (UK, US, Canada, …), in compliance with the defined schedules
Maintain the technical files, taking into account the export requirements, in compliance with the regulations in force
Elaborate the articles of conditioning
Manage product risk analysis
Evaluate the regulatory impact of modifications (design, manufacturing, etc.)
Verify that the promotional documents is in compliance with regulatory requirements
Participate in regulatory monitoring