Software and AI Specialist

Job Description We are currently looking for a Software and AI Specialist to join our Innovative Devices – Software and AI Function within the Healthcare Quality and Access group. Please note this opportunity is currently only available to those working within the Civil Service. Applications from non-Civil Servants may not be reviewed and may be rejected. This is a full-time opportunity, on a 6-month fixed term contract. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas. We are open to requests for flexible working. Please discuss this with the recruiting manager before accepting an appointment. Government departments and agencies are working towards implementing a minimum 60% attendance in office sites. We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. 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. This post is based in the Innovative Devices – Software and AI Group. The group is responsible for taking all reasonable steps to protect the 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 does this by providing technical leadership on Software as a Medical Device (SaMD) including AI as a Medical Device (AIaMD) through a range of safety, regulatory, policy and technical activities. This includes the 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 a range of issues involving SaMD and AIaMD, developing innovative policy, working with international partners in this space and undertaking activities to identify safety signals for further investigation. In response to the Secretary of State’s desire to progress at pace on the commitments in the 10 Year Health Plan, the MHRA has proposed the establishment of 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, which we are committed to publishing in 2026. The National Commission would act as an advisory group to support the MHRA to ensure patients in Great Britain have fast access to safe and effective AI devices. The postholder will lead the policy function within the AI Regulation and Policy team, providing strategic oversight and expert policy input into the regulation of advanced AI technologies. The postholder 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. What’s the role? This is an exciting time to join the AI Regulation and policy team at the MHRA, as we work to deliver the National Commission on the regulation of AI in healthcare, partner with industry to test new and innovative products through the AI Airlock and work with academia and researchers to develop a flexible proportionate approach to AI Regulation in healthcare that allows patients to access technological solutions while taking care of their safety. Key Responsibilities • Lead the policy function within the AI Regulation and Policy Team. • Assess and develop policy responses to the risks and regulatory challenges associated with advanced AI technologies, such as foundation models and generative AI, particularly in the context of healthcare. • Gather, synthesise and evaluate evidence from technical, legal, and socio-economic perspectives to inform reports, briefings, consultation responses, regulatory guidance and best practices on AI regulation in healthcare. • Engage with industry, big tech, civil society, academia, government and other regulators to inform the MHRA work and communicate policy lines. • Deputise for the Head of AI Regulation and Policy as required. • Represent the MHRA at working-level meetings, workshops and conferences, presenting the MHRA positions clearly and professionally. • Line Manage one-two AI policy and regulation advisors Who are we looking for? Our Successful Candidate Will • Demonstrate significant working experience in a policy, regulatory, technology-based or legal role. Experience of AI governance or policy is a plus. • Excellent written communication skills, including the ability to analyse complex issues and formulate clear and persuasive arguments for a range of audiences. • The ability to use good judgement and problem solving skills in order to take sound and potentially high profile decisions. • Strong interpersonal skills, including the ability to negotiate and maintain good relationships with senior officials in assigned stakeholder areas. • An understanding of wider political, economic and technological developments in the UK and overseas. • Ability to work as a member of a project team to deliver defined objectives under tight deadlines. 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 careers@mhra.gov.uk The Selection Process We use the Civil Service Success Profiles to assess our candidates, find out more here . • Online application form, including a statement of suitability, attached as a PDF of no more than 750 words demonstrating how you meet the person specification. All information that you provide will be anonymised and our Hiring Managers will not be able to access your details when reviewing your application . Please ensure not to include any personal identifying information on your supporting information. • The interview will be conducted as an informal, conversational dialogue. 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 statement of suitability provided. You can view the criteria 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 careers@mhra.gov.uk as soon as possible. Closing date: 31 st October 2025 Shortlisting date: from 3 rd November 2025 Interview date: TBC 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 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 . 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. 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 careers@mhra.gov.uk . 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, Florentina.Oyelami@mhra.gov.uk . 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 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.