Head of Approved Bodies & Market Surveillance

We are currently looking for an Head of Approved Bodies and Proactive Market Surveillance to join our Standards and Compliance Function within the Healthcare Quality and Access 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 Inspectorate, the Inspection Action Group and Devices Audit and Compliance.

The post holder is responsible for leading, managing and developing the (external) audit (proactive Market Surveillance) and Approved Body teams within the MHRA. The postholder will be responsible for the oversight of all UK approved body, manufacturer, economic operator and other international audit programmes. The engagement and liaison with stakeholders both UK and worldwide is also an important part of this role to grow and enhance the work of the MHRA to meet the ever changing and challenging regulatory environment.

Key responsibilities:

• Responsible for leading the designation and monitoring of UK Approved Bodies
• Responsible for developing and implementing the proactive market surveillance plan
• Supporting the programme for developing and implementing the new regulatory framework for medical devices
• Leading a team of auditors and regulatory specialists, including line management responsibilities and ensuring delivery of appropriate development opportunities

Who are we looking for?

Our successful candidate will demonstrate the following: 

• Leadership
• Seeing the Big Picture
• Communicating and influencing
• Knowledge and understanding of the medical device regulations
• Audit or other experience of the conformity assessment of medical devices

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! 

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 [email protected]

The selection process:

We use the Civil Service Success Profiles to assess our candidates, find out more here. 

• 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 candidates being a qualified lead auditor in accordance with ISO 13485 or other relevant experience of the conformity assessment of medical devices.

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. 

Use of AI in Job Applications

Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own.

If you require any disability related adjustments at any point during the process, please contact [email protected] as soon as possible.

Closing date: 12th October 2025

Shortlisting date: from 13^th October 2025

Interview date: from 27^th October 2025

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.

If you need assistance applying for this role or have any other questions, please contact [email protected]

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. 

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 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.

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

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 Florentina Oleylami, Head of Talent Acquisition, [email protected].  

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

[email protected]

Civil Service Commission 

Room G/8 

1 Horse Guards Road 

London 

SW1A 2HQ