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    Senior Quality and Regulatory Specialist - London, United Kingdom - King's College London

    King's College London
    King's College London London, United Kingdom

    1 month ago

    Default job background
    Full time, Fixed-Term/Contract
    Description

    Location: St Thomas' Campus

    Contact details: Dr Clare Heaysman.

    About us

    We are seeking experts in medical device design regulatory processes to join our team and work with project groups to translate novel technologies to the clinic.

    We welcome applications from individuals with experience in:

    • Regulatory Affairs supporting MedTech start-up organisations
    • Quality Management Implementation
    • Software as a Medical Device

    The post holders will be based in the London Institute for Healthcare Engineering (LIHE) part of the School of Biomedical Engineering and Imaging Sciences, King's College London.

    About the role

    Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide.

    The post holders will support a wide variety of research projects in the School and start-up companies as part of our MedTech Venture Builder and Accelerator programmes in the MedTech and Digital Health Hubs to develop new class I to class III medical devices and healthcare technology.

    They will operate within the Medical Engineering Quality Management System (QMS), developed to meet the requirements of ISO 13485 and the development of state-of-the-art medical technology, including surgical robotics, active implants, imaging software and AI.

    The post holders will be part of a growing Quality and Regulatory Team and provide guidance to project teams on regulatory strategy and planning, quality system procedures, identifying gaps in project information and processes; recommending solutions, and be responsible for developing and maintaining compliant processes and technical documentation that meet the needs of the different stakeholders within and external to the organisation.

    This is a full time post (35 Hours per week), and you will be offered a fixed term contract until 30 September 2026.


    About You

    To be successful in this role, we are looking for candidates to have the following skills and experience:

    Essential criteria

    1. Degree or equivalent experience in engineering discipline (biomedical, software, electronic, mechanical, materials), quality or related subject.
    2. Knowledge and experience applying quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.
    3. Experience in the application of design controls and risk management to medical device or SaMD design activities, e.g. writing or reviewing design plans, requirements, hazard analysis, verification and validation protocols and reports.
    4. Ability to understand regulatory needs and provide strategic advice.
    5. Experience of working to quality system procedures.
    6. Experience of preparing and writing standard operating procedures, templates and/or test method instructions.
    7. Experience of project or task prioritisation, able to handle several projects at once and work collaboratively with different teams to agreed deadlines.
    8. Excellent organisational, written and verbal communication skills and ability to troubleshoot.

    Desirable criteria

    1. Knowledge and experience of development and testing standards applied to medical devices e.g. ISO 62366, IEC 62304, IEC 60601 series, or ISO 10993 series.
    2. Auditing experience
    3. Experience in preparing regulatory submissions
    4. Experience in working with early-stage companies, where requirements are not clearly defined and where flexibility is needed

    Full details of the role and the skills and experience required can be found in the attached job description which is provided on the next page.

    £51,974 to £61,021 per annum, including London Weighting Allowance.

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