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    • This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices.
    • Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned region.
    • Monitors project budget/spending associated with planning and process aspects of Vertex sponsored medical education events, advisory boards, medical reporting,…
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    • Significant experience (typically 8+ years) within medical device industry.
    • Medical Devices: Advising on medical device quality and regulatory requirements,…
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    • Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
    • Prepares and reviews regulatory submissions.
    • As Head of International Medical Affairs, Process Effectiveness and Monitoring, you will lead the advancement of process effectiveness and monitoring across…
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    • Experience in the regulated medical device industry, ideally supporting product lifecycle and regulatory compliance activities.
    • Co-ordinate, lead and develop the team of internationally based regulatory consultants engaged in global notification services (ca. 10 - 15 staff).
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    • 3–7 years' experience in regulatory affairs, medical device compliance or related regulatory function.
    • Supporting regulatory strategy and submission planning…
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    • Domain: Class III medical device · regulatory affairs.
    • Supporting the development and maintenance of regulatory strategies for Class III medical device…
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    • 3+ years' experience in regulatory affairs, medical device compliance or related regulatory role.
    • Supporting the development and maintenance of regulatory…
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    • Strong governance, compliance, and risk management expertise within a global regulatory environment.
    • Complex Problem Solving: Resolve highly ambiguous…
    • Prior experience supporting medical device submissions or regulatory inspections.
    • Understanding of Class III medical device regulatory requirements and product…
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    • Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device regulatory pathways.
    • 2–5 years' experience in regulatory affairs, quality assurance or…

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Job Post Details

Medical Device Auditor
Computer Futures
·
3.8
London
£75,000 a year
Permanent
Apply on company site

Job details

£75,000 a year
Cycle to work scheme
Permanent
London

Full job description

Medical Device Auditor - London / Remote We are partnering with our client to help them appoint a Medical Device Auditor. This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices. Key Skills & Experience
  • Medical Device Industry Experience (4+ years)
  • ISO 13485 QMS Auditing/Management
  • EU MDR / UK MDR for QMS
  • Software & SaMD Expertise desirable
Offered:
  • Up to £90,000 per annum
  • Share options
  • EV and cycle to work scheme
Interested? If you are looking to apply your quality expertise in a high-impact role within our client's team, please apply to this with your CV and we'll be in touch! To find out more about Computer Futures please visit www.computerfutures.com Computer Futures, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales
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