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    Regulatory Affairs Specialist - Utrecht, Nederland - Undutchables

    Undutchables
    Undutchables Utrecht, Nederland

    4 dagen geleden

    Default job background
    Beschrijving
    Key activities/main objectives
    • Manage and ensure compliance with regulatory requirements for the product portfolio.
    • Provide regulatory affairs (RA) support for research and development Key activities/main objectives
      • Manage and ensure compliance with regulatory requirements for the product portfolio.
      • Provide regulatory affairs (RA) support for research and development (R&D) projects and product modifications.
      • Maintain up-to-date technical documentation for the SCI product lineup.
      • Assess product conformity and oversee the conformity assessment process.
      • Offer technical and RA expertise for the approval of medical devices.
      • Facilitate the global registration process for all products.
      • Stay informed about and communicate relevant changes in regulatory legislation and guidelines.
      • Report to the RA director or designated authority.
      • Master's Degree or equivalent experience in Engineering, Pharmacy, Chemistry, or a related life science field.
      • Familiarity with relevant regulations such as MDR, FDA 21 CFR 820, SOR98-282, and TGA, as well as guidelines like FDA, MDGG, and MEDDEV.
      • Knowledge of applicable ISO standards.
      • Proficiency in project management.
      • Strong verbal and written communication abilities.
      • You are available for 32-40 hours.
      • You live close to Amersfoort.
      • You have a valid working permit.
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