Regulatory Expert - Sapiranga - beBeeMedicalDeviceExpert

    beBeeMedicalDeviceExpert
    beBeeMedicalDeviceExpert Sapiranga

    há 5 dias

    Título do emprego: Regulatory Affairs Specialist

    Descrição
    Job Overview:

    A Regulator with expertise in medical devices is required to lead regulatory activities ensuring compliance with European regulations. The role involves providing strategic support to clients across multiple industries, analyzing and managing regulatory changes, and ensuring compliance with post-market requirements.



    Key Responsibilities:
    • Lead Regulatory Affairs activities for medical devices, including classification, documentation, CE marking processes, conformity assessments and post-market surveillance.
    • Analyze and manage regulatory changes affecting product portfolios.
    • Provide expert support on regulatory matters throughout the device lifecycle.



    Vacancy Requirements:

    The ideal candidate will have 6+ years of experience in Regulated affairs for medical devices. A strong understanding of EU MDR (Regulation (EU) 2017/745) is essential along with expertise in Class IIa and IIb medical devices. Additionally a proven track record of working with Notified Bodies & Health Authorities as well as knowledge of the full life cycle regulation process is necessary

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