Chief Medical Device Compliance Officer - Londrina, PR - beBeeClassification

    beBeeClassification
    beBeeClassification Londrina, PR

    há 4 dias

    Tempo integral

    Título do emprego: Regulatory Affairs Specialist

    Descrição

    Regulatory Affairs Specialist Role

    We are seeking a highly skilled Regulatory Affairs Specialist to lead our medical device regulatory activities and ensure compliance with EU MDR regulations.

    • Develop and implement effective strategies for Class IIa and IIb medical device classification, ensuring seamless coordination with cross-functional teams.
    • Collaborate closely with stakeholders to prepare, review, and maintain technical documentation, including Annexes II and III.
    • Provide expert support on CE Marking processes, conformity assessments, direct interaction with Notified Bodies, and analyze/manage regulatory changes to assess their impact on product portfolios.

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