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  • Regulatory Affairs Specialist Ivd

    12 noviembre 2021

    Randstad Consultores Soluciones HR , San Sebastián de los Reyes (Madrid)

    Indefinido, 40.000€ al Año


    The Regulatory Affairs Specialist supports the planning and execution of regulatory activities for the registration of the assigned product portfolio. This position is actively supporting the product teams to make the products and related documentation compliant to the national and international requirements.The Regulatory Affairs Specialist serves as a subject matter expert for creation of regulatory reports and regulatory requirements. He/she will drive results through being a well-organized team player with a focused and disciplined approach to achieve the joint goals. These are your new key responsibilities:You actively support all pre-market and post-market regulatory activities of the assigned product portfolioYou keep track of the national and international requirements for product registrationsYou work with the product teams to ensure the products and related documentation are compliant with the regulatory requirementsYou support with national registrations and the regulatory transformation for compliance to the new EU IVD Regulation 2017/746.You create registration dossiers used for registration at international authorities.

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