Regulatory Affairs Specialist for Medical Devices
il y a 4 semaines
We are seeking a Regulatory Affairs Specialist for Medical Devices to join our team at ProductLife Group in Paris.
Responsibilities- Develop and maintain registration dossiers in accordance with European regulation (2017/745) and other specific requirements.
- Coordinate with contributors (R&D, Production, QA, Clinical) to ensure dossier constitution meets regulatory requirements.
- Maintain technical files, considering export requirements and regulatory compliance.
- Elaborate articles of conditioning and manage product risk analysis.
- Evaluate the regulatory impact of modifications (design, manufacturing, etc.).
- Verify promotional documents comply with regulatory requirements.
- Participate in regulatory monitoring.
- Master's degree in a science-related field.
- Minimum 2 years of experience in regulatory affairs for medical devices.
- Mastery of regulations on priority subjects expected.
- Knowledge of Italian decree 116/2020 on packaging is a plus.
- Knowledge of new European regulation (2017/745).
- Good communication skills and attention to details.
- Fluent in both French and English is mandatory.
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