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  • Graduate Regulatory Affairs – Medical Devices - Royal Leamington Spa, England - Graduate Talent

    Graduate Talent
    Graduate Talent Royal Leamington Spa, England

    2 months ago

    Description

    Graduate Regulatory Affairs Associate – Medical Devices

    Location: Leamington Spa, UK | Office-based (occasional travel)

    Reports to: Business Director

    Join a market-leading healthcare company with over 40 years of global experience. Our client manufactures high-quality medical devices in the UK and supply products to over 70 countries.

    This is a fantastic opportunity to start your career in a
    specialist field within the life sciences industry
    and gain
    hands-on experience in a growing SME,
    learning the business from the bottom up.

    The Role:

    As a Graduate Regulatory Affairs Associate, you will support the compliance of our medical device portfolio with international regulations.

    Responsibilities include:

    • Compliance assurance
    • Ensuring that medical devices meet all legal requirements before they are sold
    • Product development support
    • Guiding the development and lifecycle management of new and existing medical devices to ensure they meet regulatory standards
    • Market surveillance
    • Monitoring the performance and safety of devices already on the market and reporting any issues to the appropriate regulatory body
    • Documentation and submissions
    • Preparing and submitting required documentation to regulatory agencies for approval
    • Risk assessment
    • Analysing and managing the risks associated with medical devices to ensure patient safety
    • Liaising with authorities such as the MHRA
    • Communicating with regulatory bodies, such as MHRA, to provide information and address concerns

    While primarily office-based, the role involves occasional travel to manufacturing sites and trade shows, so a full UK driving licence is required.

    Requirements:

    • Graduate in Biomedical Engineering, Biochemistry, Life Sciences, or a related discipline
    • Strong attention to detail, communication, and analytical skills
    • Excellent communication skills
    • An understanding of regulatory affairs
    • Right to work in the UK (sponsorship not provided)

    What We Offer:

    • Competitive salary
    • Structured training and mentoring in Medical Regulatory Affairs
    • Supportive and Friendly Team
    • Exposure to global compliance frameworks and career progression opportunities
    • Free on-site parking, early finish at 2:30pm Fridays, company pension scheme

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