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    Regulatory Affairs Officer 610 - Paris, France - ProductLife Group

    ProductLife Group
    ProductLife Group Paris, France

    il y a 5 jours

    Default job background
    Permanent contract
    Description

    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
  • 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
    • 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)
  • Good communication skills
  • Attention to details
  • Fluent in both French and English is mandatory
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