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    Senior Regulatory Affairs Associate - United Kingdom - Terumo Aortic

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    Description

    Terumo Aortic are looking for a Senior Regulatory Affairs Associate to join our team during an exciting time of growth and expansion for the business. This is a fantastic opportunity for someone to join our Regulatory Affairs team in a rewarding role with a company that offers career development amongst a host of excellent benefits.

    Key Duties :-

    • Assist in the productionand review of design dossiers technical files, and Product Approval Certificates.
    • Preparation of regulatory submission for product approvals.
    • Preparation of Custom Made device, Special Products paperwork and change assessments.
    • Participate in Design Control, Risk Management, Post Market Surveillance and document changes.
    • Facilitate compliance with Vigilance System.
    • Update and review all IFU, Packaging and Labelling
    • Other duties as required by Regulatory Affairs department

    Qualifications & Experience :-

    • BSc Hons Degree or equivalent.
    • Regulatory experience within a medical device or pharmaceutical environment is desirable.
    • Class 3 Medical device experience preferred

    This role can be remote based with occasional travel to our Glasgow site.

    #J-18808-Ljbffr


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