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    Regulatory Affairs and Quality Manager - Edinburgh, United Kingdom - Weare5vtech

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    Description
    Senior Quality and Regulatory Affairs Manager
    Permanent contract
    Remote, office located in Berlin, Germany - Must travel on-site once a month
    Are you an experienced QA Manager with experience in regulatory affairs and ISO?

    They are a passionate team of visionaries and engineers looking to revolutionise med-tech, in particular linked to women health.

    Though this position is remote, you will have to be able to travel to the Berlin office once a month, and therefore be in the EU area.

    Take care of the implementation and maintenance of a Quality Management System (QMS) that complies with ISO 13485, ISO 14971, IVDR and FDA 510(k)

    • Ensure that the processes and products meet all necessary quality and regulatory requirements before they reach the users
    - (In English, though it could also be in German) Communicate with Notified Body and other responsible authorities

    • Experience with regulatory affairs for medical devices and QMS
    • Knowledge of, or experience with, invitro diagnostic medical devices regulation (MDD / MDR) IVDR and CFR
    • Exceptional communication skills, attention to detail and project management experience or knowledge
    Able to speak German to B1/B2 level
    -


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