Software and AI Specialist - £60,778 - £68,422 p.a. + benefits

Job summary

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.1700 staff working across two main centres and peripatetically across the UK and abroad.

The agency consists of Corporate, Partnerships, Transformation, Governance, Communications & Engagement, Scientific Research & Innovation, Healthcare Quality & Access, Safety & Surveillance and Technology groups.

About the Division

This post is based in the Software and AI team, which is part of the Innovation and Compliance Group.

The group is responsible for taking all reasonable steps to protect public health and safeguard the interests of patients by ensuring that software and AI as a medical device meet all appropriate standards of safety and performance and to encourage safe use.

The Group provides technical, policy and regulatory leadership on software and AI-enabled medical devices through a range of safety, regulatory, policy and technical activities. This includes:

• Review of clinical investigations.
• Review of applications for exceptional use.
• Undertaking technical file reviews to underpin compliance activity.
• Engaging with internal and external stakeholders on issues involving software and AI-enabled medical devices.
• Developing innovative policy and programmes.
• Working with international partners.
• Undertaking activities to identify safety signals for further investigation.

In response to the Secretary of State’s desire to progress commitments in the 10 Year Health Plan, the MHRA established an expert, non-statutory National Commission into the Regulation of AI in Healthcare to inform the development of a new regulatory framework for AI in healthcare and provide recommendations in 2026.

The National Commission is providing recommendations to the MHRA and the broader healthcare system to ensure patients in Great Britain have fast access to safe and effective AI devices. The MHRA will implement these recommendations through the design of an updated framework for AI Medical Devices and by driving policy and programme change for software and AI-enabled medical devices.

Job description

The postholder will be responsible for the following:

• lead and contribute to policy development on software and AI-enabled medical devices,
• lead technical reviews and enquiries on software and AI-enabled medical devices,
• lead and support the international and domestic programmes of work on AI and software enabled medical device.

The postholders will play a pivotal role in helping to shape the UK’s approach to AI governance in healthcare, ensuring that regulatory frameworks are evidence-based, future-proof, and aligned with public interest

Key responsibilities and results areas

Leadership and Management

• Lead part of the policy function within the AI and Software Policy Team. This may include: lead technical reviews and enquiries on software and AI-enabled medical devices or lead the international programme of work on AI and software as a medical device.
• Take responsibility for delivering discrete projects or work packages within the regulation of AI in healthcare, meeting defined objectives under tight deadlines and reporting progress, decisions and risks to senior colleagues.
• Be proactive and independent whilst also being a strong team player, working purposefully towards achieving programme goals.
• Line manage 1-2 or more advisors.

Service Delivery

• Assess and develop policy responses to the risks and regulatory challenges associated with advanced AI technologies, such as foundation models and generative AI, drawing on sound judgement, problem-solving skills and an understanding of the wider political, economic and technological context in the UK and internationally.
• Provide regulatory advice and guidance on the implementation and interpretation of the current and future software and AI-enabled medical devices regulatory framework, applying experience in policy, regulation, technology, law and/or AI governance.
• Gather, synthesise and evaluate complex evidence from technical, legal, operational and socio-economic perspectives to inform the development of primary and secondary legislation on software and AI-enabled medical devices regulation.
• Produce clear, accurate and persuasive policy products, including reports, briefings, consultation responses, regulatory guidance and best practice materials, tailored to a range of audiences.
• Represent the MHRA at working-level meetings, workshops and conferences, presenting MHRA positions clearly, professionally and with sensitivity to high-profile policy and regulatory issues.

Service Improvement

• Engage, negotiate and maintain effective relationships with industry, civil society, academia, government, other regulators and senior officials to inform the MHRA’s work and communicate policy positions.
• Work closely with colleagues across the Software and AI team, Innovation and Compliance Group and wider Agency to ensure joined-up delivery of AI and Software as a medical device regulation projects.
• Forge productive relationships with external parties to support successful programme delivery.

Quality and Assurance

• Gather, analyse and evaluate complex evidence to support robust regulatory and policy decisions.
• Ensure policy products, guidance and advice are clear, accurate and evidence based.

General

• Deliver difficult or complex messages with decisiveness, clarity and sensitivity, being persuasive when required.
• Promote diversity, inclusion and equality of opportunity, respecting difference and external experience.
• Demonstrate commitment to continuous self-learning, development, innovation and challenge.
• Be proactive and independent in managing work whilst contributing effectively as part of a wider team.

The job description is not intended to be exhaustive and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the postholder.

• lead a portfolio of the international or domestic programme of work on AI and software enabled medical device,

The postholders will play a pivotal role in helping to shape the UK’s approach to AI governance in healthcare, ensuring that regulatory frameworks are evidence-based, future-proof, and aligned with public interest.

Person specification

• Significant experience working in a policy, regulatory, technology-based or legal role.
• Experience on AI governance or policy in the context of healthcare / medical devices.
• Excellent written communication skills, including the ability to analyse complex issues and formulate clear and persuasive arguments for a range of audiences.
• Strong interpersonal skills, including the ability to negotiate and maintain relationships with senior officials and stakeholders, and the ability to act independently.
• An understanding of wider political, economic and technological developments in the UK and internationally.
• Previous relevant experience such as healthcare, medical device, AI governance or regulation or regulatory environment.

Behaviours

We'll assess you against these behaviours during the selection process:

• Seeing the Big Picture
• Leadership
• Making Effective Decisions
• Delivering at Pace

Benefits

Alongside your salary of £60,778, Medicines and Healthcare Products Regulatory Agency contributes £17,607 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of six months full pay and six months half pay after five years’ service.
• Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
• Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666
• Flexible working to ensure staff maintain a healthy work-life balance
• Interest free season ticket loan or bike loan
• Employee Assistance Services and access to the Civil Service Benevolent Fund
• Eligibility to join Motoring , Boundless by CSMA
• Variety of staff and Civil Service clubs
• On-going learning and development

Things you need to know

Artificial intelligence

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 (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

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

Key dates (dates are indicative only and could be subject to change)

• Closing date – 6th October 2026 at 23:55
• Sifting – week commencing 7th October 2026
• Main panel interviews – week commencing 12th October 2026

Communications will be electronic via email therefore it is important that you check your Civil Service Jobs account regularly, as well as your spam/junk email folder.

We’re committed to being diverse and inclusive, so please make your application anonymous by removing all identifying personal information (such as names and dates) from your employment history and personal statement.

1. Sift Stage

• Anonymised CV which sets out your career history, previous experience and skills, highlighting specific responsibilities that are relevant for this role.
• 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

The panel will look at your application and are looking for evidence of the stated points. We may raise the benchmark score required if we receive a high number of applications.

1. Main Panel Interview

Successful candidates from the sift stage will be invited to attend an interview. We use a blended interview technique, allowing us to find out more about you. We use the Success Profile framework and at interview we will be assessing Behaviours and Experience.

Your interview will include:

• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.

At interview, we will be asking questions relating to the following:

• Behaviours: Leadership, Seeing the Big Picture, Making Effective Decisions and Delivering at Pace
• Experience, as listed in the person specification
• Strengths

Feedback will only be provided if you attend an interview.

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

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 availablehere.

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.

Security

Successful candidates must undergo a basic (or equivalent) criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

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)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

This vacancy is part of the Great Place to Work for Veterans (opens in a new window) initiative.Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : The Resourcing Team
• Email : careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk

Further information

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 contact the Resourcing team at Careers@mhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ

Attachments

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