Expert Auditor

Medicines and Healthcare products Regulatory Agency; Greater London, South Mimms; On-site; GBP 70,000 - 95,000; Full time

Job summary

Medicines and Healthcare products Regulatory Agency seeks an Expert Auditor for the Devices Compliance and Audit team. The role is homebased within the UK with occasional travel to London and Hertfordshire.

It focuses on audit strategy, policy and regulatory leadership to influence medical device auditing globally. The successful candidate will have extensive knowledge of Medical Device Regulations, hands-on auditing experience including MDSAP, and strong leadership capabilities.

Qualifications

• Extensive knowledge of Medical Device Regulations and industry practice.
• Proven track record of undertaking medical device audits, including MDSAP where possible.
• Breadth of understanding and practical experience underpinning audit for medical device regulations.

Responsibilities

• Lead the work related to MHRA joining the MDSAP programme and act as technical lead.
• Steer Devices audit horizon scanning and prepare for emerging developments.
• Develop the Devices audit strategy and inspection models in line with agency priorities.
• Provide technical leadership, mentorship and guidance within the Devices Compliance & Audit Teams.

Skills

Medical device regulations

Audit leadership

MDSAP audits

Regulatory affairs

Education

Degree in a relevant discipline

Job description

as soon as possible.

Closing date: 02 September 2026

Job Description

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 homebased 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

• 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)

The Selection Process

• Online application form, including questions based on the Behaviour, Experience, Technical and Strengths 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.

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.

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.

Use of AI in Job Applications

Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factual 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 for more information on appropriate and inappropriate use.

Role

Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens
• Maintenance roles, particularly those required to work in laboratory settings
• Roles that involve visiting other establishments where vaccination is required
• Roles required to travel overseas where specific vaccination may be required.

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.

Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide proof information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here .

Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms. If an individual is in any doubt, they should seek clarification before accepting a job offer.

Staff joining on promotion will receive up to a 10% increase of their current basic salary, or the pay band minimum, whichever is the greater.

The individual will not retain any allowances paid by the former department/Agency, unless there are special circumstances, such as a reserved right to those allowances on transfer.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact [e-mail].

In accordance with the Civil Service Commissioners' Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact [e-mail]

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk

[e-mail]

Civil Service Commission

Room G/8

1 Horse Guards Road

London

SW1A 2HQ

About Us

ABOUT US

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 agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.

The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.

Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact [e-mail]

Closing date: 02 September 2026

Shortlisting date: w/c 07 September 2026

Interview date: w/c 14 & 21 September 2026

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here .