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    Regulatory Affairs Specialist - Aachen, Deutschland - BioTalent

    BioTalent
    BioTalent Aachen, Deutschland

    vor 1 Woche

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    Beschreibung

    Role: Regulatory Affairs Specialist

    Location: Aachen

    About Us: This company is a a leading innovator in Medical Device specifically within the area of cardiology specifically manufacturing class II Devices

    Key Responsibilities:

    • Ensure compliance with regulatory requirements.
    • Prepare and submit regulatory technical documentation such as participation in the creation of validation and risk management documentation, UDI management, qualification and classification)
    • Collaborate with cross-functional teams.
    • Provide guidance and support to internal teams.

    Qualifications:

    • Strong understanding of FDA, EU, and international regulations
    • Experience within the Medical Device space specifically working with class II or class III products
    • German speaking is required
    • Excellent communication and problem-solving skills.

    To join a dynamic team shaping the future of healthcare regulation and compliance. Send your cv to or click apply

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