Medicines and Healthcare products Regulatory Agency
Expert Auditor
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We are currently looking for an Expert Auditor to join our Devices Compliance and Audit Function within the Innovation and Compliance group.
This is a full-time opportunity, on a permanent basis. The role is a home-based role but will require occasional travel to 10 South Colonnade, Canary Wharf London, E14 4PU/South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas.
Who are we?
The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
The objective of the Healthcare Quality and Access Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.
The Standards & Compliance function will enable innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Compliance Teams, the Inspection Action Group and Devices Audit and Compliance.
What’s the role?
The expert auditor will perform a crucial role in developing the agency’s medical device audit strategies & legislation, providing technical leadership, guidance and support to the Devices Compliance & Audit Team. They will achieve this through engagement with industry, government and regulatory partners at a national and international level, influencing the global approach to medical device auditing and development of audit practices.
Key responsibilities:
- To lead the work relating to MHRA becoming a full member of the MDSAP programme, taking account of technical, policy and regulatory issues. Working with key stakeholders across the agency to ensure MHRA’s application is successful. They will then act as the technical lead for MDSAP for the agency.
- To lead Devices audit horizon scanning activities, provide advice on the required team direction to prepare for emerging developments.
- To lead the development of the Devices audit strategy and inspection models linking Agency and Government priorities to the work of the Devices Compliance and Audit Team.
- Providing sound technical leadership and support, mentorship and guidance to auditors and Inspectors in the Devices Compliance & Audit Teams, as well as technical specialist based in other teams.
Who are we looking for?
Our successful candidate will have the following:
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- Changing and Improving - Challenge the way things have always been done and suggest improvements, learning from experience. Encourage measured risk taking and innovation to deliver better approaches and services. Implement changes that transform flexibility, responsiveness and quality of service. Ensure changes add value to the business and express clearly how and why changes are necessary.
- Seeing the Big Picture - Create joined up strategies that put into practice and support the Government’s vision for the future. Identify and shape how your work area fits within and supports the priorities of the organisation.
- Communicating and Influencing - Communicate with others in a clear, honest and enthusiastic way in order to build trust. Explain complex issues in a way that is easy to understand. Take into account people’s individual needs. Deliver difficult messages with clarity and sensitivity, being persuasive when required.
- Extensive knowledge of Medical Device Regulations and industry practice coupled with a broad understanding of the work of the Devices Compliance & Audit Team and the MHRA.
- Proven track record of undertaking medical device audits. Experience of MDSAP audits is desirable
Person Specification:
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
- Changing and Improving (A, I, P)
- Leadership (A, I, P)
- Seeing the Big Picture (A, I, P)
- Communicating and Influencing (A, I, P)
- Making Effective Decisions (A, I)
- Developing Self and Others (A, I)
Experience Criteria:
- Extensive knowledge of Medical Device Regulations and industry practice coupled with a broad understanding of the work of the Devices Compliance & Audit Team and the MHRA. (A, I, P)
- Proven track record of undertaking medical device audits. Experience of MDSAP audits is desirable (A, I)
- A breadth of understanding and practical experience of modern concepts and practicalities underlying audit for the purpose of medical device regulations (A, I)
Technical Criteria:
- Educated to degree level in a relevant discipline or equivalent experience developed through previous roles. (A, I)
- Good verbal and numerical reasoning skills to allow the analysis and interpretation of written and numerical data. (A, I)
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! https://mhra-gov.filecamp.com/s/d/6Nysi22zRZLcujWt
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The selection process:
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We use the Civil Service Success Profiles to assess our candidates, find out more here https://www.gov.uk/government/publications/success-profiles.
- Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
- Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of: Proven track record of undertaking medical device audits.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.
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Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance [https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.civil-service-careers.gov.uk%2Fartificial-intelligence-and-recruitment%2F&data=05%7C02%7CUfuoma.Eriemo2%40mhra.gov.uk%7C3d175bf263f54c3cf85608de3bfa288f%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C639014142773052769%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2VE8qZPdzo8azEL775DBoKUPz5zMHopZPjc9cs3KuOk%3D&reserved=0](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.civil-service-careers.gov.uk%2Fartificial-intelligence-and-recruitment%2F&data=05%7C02%7CUfuoma.Eriemo2%40mhra.gov.uk%7C3d175bf263f54c3cf85608de3bfa288f%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C639014142773052769%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&s
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