Regulatory Affairs Specialist

il y a 3 jours


Paris, Île-de-France ProductLife Group Temps plein
Regulatory Affairs Officer

We are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group in Paris.

Responsibilities
  • Develop and maintain regulatory dossiers in accordance with European regulations (2017/745) and other international requirements.
  • Coordinate with cross-functional teams to ensure compliance with regulatory schedules and requirements.
  • Maintain technical files, including export requirements, in compliance with regulations.
  • Prepare articles of conditioning and manage product risk analysis.
  • Evaluate the regulatory impact of modifications and verify promotional documents for compliance.
  • Participate in regulatory monitoring and stay up-to-date with industry developments.
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 the Italian decree 116/2020 on packaging and the new European regulation (2017/745) is a plus.
  • Excellent communication skills and attention to detail.
  • Fluency in both French and English is mandatory.


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