Regulatory Affairs Lead - £42,410 - £51,666 p.a. + benefits

We are currently looking for a Regulatory Affairs Lead to join our Standards & Compliance Function within the Devices Compliance and Audit group.

This is a permanent full-time opportunity. The role is a home-based role but will require occasional travel to 10 South Colonnade, Canary Wharf London, E14 4PU or South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas.

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 enables 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.

Role Purpose

This role is primarily responsible for providing regulatory support to the Agency’s proactive Market Surveillance and Approved Body Team. The post holder will be responsible for supporting senior management with the planning and coordination of MHRA’s proactive Market Surveillance plan which includes direct audits of medical device manufacturers (including economic operators) and review of technical documentation together with the development and delivery of the Approved Bodies plan. In addition, the post holder will provide regulatory support and scrutiny of medical device manufacturers (including economic operators) registering their devices with the MHRA.

The registration system will be crucial in MHRA’s future and the proactive Market Surveillance strategy. The post holder will be key in identifying and providing significant trends to senior colleagues and setting up of audits and off-site technical file review, all whilst ensuring the Agency’s post audit targets are met, CAPA plans assessed and monitored as well as feeding into wider discussions around the impact on the product being available on the UK market. More broadly, the post holder will provide support to senior managers, feeding into, pulling together and implementing proposals and projects to expand the MHRA’s role in the areas of proactive Market Surveillance, and Approved Body oversight together with supporting the wider team and senior colleagues by providing regulatory advice to stakeholders.

Key responsibilities and results areas

Leadership and management

• Lead and coordinate key projects supporting delivery of the Approved Body oversight plan and proactive Market Surveillance strategy, ensuring clear milestones, tracking, and timely delivery
• Provide insight and feedback to senior management on progress, risks, and operational challenges to inform decision making
• Drive cross-team collaboration to ensure alignment and effective delivery of project activities
• Train regulatory specialists and assessors on new processes, monitor progress, and escalate concerns where required
• Represent MHRA at both internal and external meetings. Building effective relationships with colleagues, Approved Bodies, manufacturers, and other key stakeholders

Service delivery

• Develop and manage the audit schedule, ensuring audits and technical file reviews are effectively planned and delivered
• Participate in internal panel meetings to present audit/review status and provide recommendations on next steps
• Review escalated registration requests and provide regulatory advice on acceptance
• Provide regulatory advice to internal and external stakeholders, including participation in borderline meetings and discussions with manufacturers and Approved Bodies on CAPA plans
• Deliver clear, well-reasoned written and verbal regulatory advice, including responses to enquiries, FOIs, Parliamentary Questions, ministerial briefings, and compliance cases

Service improvement

• Identify opportunities to improve processes and systems to enhance delivery of the ABMS programme
• Support strategic monitoring of the marketplace and contribute to proactive Market Surveillance and Approved Body plans
• Use registration trends, audit outcomes, and market intelligence to identify patterns, emerging risks, and inform surveillance activities

Quality and Assurance

• Support oversight of audit and technical file review processes to ensure quality, consistency, and compliance
• Ensure audit scheduling and delivery meets organisational standards and priorities
• Provide input into internal policy development to strengthen regulatory and operational frameworks

General

• Work with stakeholders to build understanding of proactive market surveillance
• Build and maintain effective professional relationships with colleagues, Approved Bodies, manufacturers, and other stakeholders

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours, Strengths, Experience and Technical skills.

• An anonymised CV outlining your job history and previous skills/experience that demonstrate how you meet the essential criteria.
• 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.
• 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: Knowledge and understanding of the Medical Device Regulations, medical device vigilance, complaint handling, risk management, and regulatory reporting.

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

Closing date: 05 October 2026

Shortlisting date: From 06 October 2026

Interview date: From w/c 19 October 2026

If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk

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.

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.

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.

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 careers@mhra.gov.uk.

Feedback will only be provided if you attend an interview or assessment.