Regulatory Affairs Specialist

3 weken geleden


Utrecht, Nederland Undutchables Voltijd
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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