Medical Device Compliance Expert - Indaial - beBeeregulatoryaffairs

    beBeeregulatoryaffairs
    beBeeregulatoryaffairs Indaial

    há 1 semana

    Título do emprego: Regulatory Affairs Specialist

    Descrição

    Job Description:


    We are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of the organization, you will be responsible for ensuring compliance with European regulations (EU MDR) and providing expert support in CE Marking processes.


    Mission Overview:



    • To lead Regulatory Affairs activities for medical devices, ensuring compliance with EU MDR regulation 2017/745.

    • To act as an expert in medical device classification, focusing on Class IIa and IIb devices.

    • To coordinate the preparation, review, and maintenance of technical documentation (EU MDR Annexes II and III).

    • To provide expert support in CE Marking processes and conformity assessments, including direct interaction with Notified Bodies.

    • To analyze and manage regulatory changes, assessing their impact on product portfolios.
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