Regulatory Affairs Specialist for Medical Devices

il y a 4 semaines


Paris, Île-de-France ProductLife Group Temps plein

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.
Profile
  • 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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