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    Medical Engineer - United Kingdom - Austin Vita

    Austin Vita
    Austin Vita United Kingdom

    4 days ago

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    Description

    Austin Vita are pleased to offer an exciting opportunity for a hands on Regulatory Engineer to join our client, an innovative medical device business who design, develop and manufacture a range of devices for global markets based in Buckinghamshire.

    The opportunity comes at a time of site expansion and natural growth within the Quality & Regulatory department, and your responsibilities will include:


    Working with internal departments and external regulators, suppliers and customers with a broad remit to ensure the ongoing product and systems compliance to the applicable regulations and standards.

    Working with the design department to ensure ongoing regulatory compliance of current and new products.

    Collaborating with a team of design engineers to produce a variety of technical documentation (such as essential requirements, risk assessments, test reports, etc).

    Producing documentation in compliance with the relevant regulatory standards.
    Assisting in the actioning of regulatory requirements associated with NCRs, customer complaints, CAPA reports etc.

    Broad background in regulatory compliance of systems and products within a QMS.
    Broad background in electro/mechanical products highly desirable, along with an understanding of the impact of regulatory requirements.
    Experience of medical standards and European/ FDA regulations highly desirable.
    Experience of medical device manufacturing and medical standards highly desirable.

    Preferably degree educated in a technical subject, such as Engineering, or in a another subject with experience of technical industry.


    You will be rewarded with a great salary and benefits including company bonus, so if this sounds of interest please apply ASAP.

    Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

    We respect your personal data and would never offer it to third parties For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Noticeor contact Austin Fraser International Ltd is registered in England: Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
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