Regulatory Affairs Officer 610
il y a 4 jours
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
Profile
Master’s degree in a science related field
Minimum of 2 years of experience in regulatory affairs for medical devices
Knowledge of the Italian decree 116/2020 on packaging is a plus
Knowledge of the new European regulation (207/745)
Good communication skills
Attention to details
Fluent in both French and English is mandatory
**Job Type**: Permanent
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