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.

Group 10 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
• Evaluate the regulatory impact of modifications (design, manufacturing, etc.)
• Verify that the promotional documents is in compliance with regulatory requirements
• Participate in regulatory monitoring

Group 13 Profile

• Master’s degree in a science related field
• Minimum of 2 years of experience in regulatory affairs for medical devices
• Mastery of regulations on priority subjects expected
• Knowledge of the Italian decree 116 / 2020 on packaging is a plus
• Knowledge of the new European regulation (207 / 745)
• Fluent in both French and English is mandatory