This vacancy is open to all Civil Service employees and employees of accredited non-departmental public bodies (NDPBs) who were appointed on merit following a fair and open competition; or were appointed to a permanent post through an exception in the Civil Service Commissioners' rules.
We are currently looking for a AI Airlock Regulatory Lead to join our Innovative Devices function within the Innovation and Compliance group.
This is a full-time opportunity, on a 12 month fixed term contract, internal move, loan or temporary promotion basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.
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.
The Innovation and Compliance (I&C) group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which balances innovation against sustainability and affordability. It is divided into four sub-groups: Innovation Accelerator and Regulatory Science, Clinical Investigations and Trials, Standards and Compliance and Innovative Devices.
The Software and AI Team is responsible for taking all reasonable steps to protect the public health and safeguard the interests of patients by ensuring that software as a medical device (SaMD) meet all appropriate standards of safety and performance and to encourage safe use. The Group does this by providing technical support and advice to the Policy Group; contributes to the review of clinical investigations and compliance activity; and engages with internal and external stakeholders on a range of issues involving software as a medical device. Following the UK exit from the EU, the Software Group is now leading on the development of a new regulatory framework for software as a
What’s the role?
A key aspect of the role will be to support the MHRA’s work in understanding how to update our regulatory framework to account for AI as a medical device.
This is an important role acting as a lead for AI-Airlock and the primary interface with associated project stakeholders.
There are three core elements to this role:
To serve as the lead on technical and regulatory expertise for the AI-Airlock project;
To work with colleagues within the project team, innovative devices and across the MHRA to take forward the AI Airlock project and
To ensure the delivery of the AI Airlock project objectives, working alongside operational expertise and management.
Key responsibilities:
Lead on the delivery of the AI Airlock programme. Engaging with academic networks, developers of AI, regulatory experts and clinicians to understand and address key technical regulatory challenges across different therapeutic areas and AI technologies. The post-holder must therefore possess technical knowledge of current regulations as they apply to software and AI, and familiarity or expertise with software and AI technology.
The postholder will possess demonstrable experience of the development of regulatory policy in the healthcare space.
Identify AI workstreams across the Agency and government, spot opportunities and collaborate to break down silos.
Lead the team of technical case managers and support engagement with innovators
Who are we looking for?
Our successful candidate will demonstrate the following:
Leadership - A proven leader, visible, empowering others, building resilience, and leading improvements.
Seeing the Big Picture – ensure plans and activities in your area of work reflect wider strategic priorities and communicate effectively with senior leaders to influence future strategies. Bring together views, perspectives, and diverse needs of stakeholders to gain a broader understanding of the issues surrounding policies and activities.
Working together - Works effectively as part of a multi-disciplinary team to maintain positive working relationships, working across boundaries and adding value through strategic thinking.
Bachelor’s degree in a relevant discipline e.g. science, engineering, medicine or equivalent experience developed through previous roles.
Demonstrable understanding of relevant directives and regulations, particularly UK MDR 2002 and SaMD guidance
Person Specification:
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
Leadership - A proven leader, visible, empowering others, building resilience, and leading improvements. (A, I)
Seeing the Big Picture – ensure plans and activities in your area of work reflect wider strategic priorities and communicate effectively with senior leaders to influence future strategies. Bring together views, perspectives, and diverse needs of stakeholders to gain a broader understanding of the issues surrounding policies and activities. (A, I)
Working together - Works effectively as part of a multi-disciplinary team to maintain positive working relationships, working across boundaries and adding value through strategic thinking. (A, I)
Experience Criteria:
Demonstrable experience of effective use of resources to meet agreed workload priorities and allocation of staff. (A, I)
Extensive and proven ability to work with discretion and capability in own area, providing effective support and specialist advice. (A, I)
Proven ability of leading projects/investigations and liaising with stakeholders e.g. DHSC, Approved Bodies and Industry (A, I)
Excellent written and oral communication skills including grammatical/technical writing skills (A, I)
Technical Criteria:
Bachelor’s degree in a relevant discipline e.g. science, engineering, medicine or equivalent experience developed through previous roles. (A, I)
Demonstrable understanding of relevant directives and regulations, particularly UK MDR 2002 and SaMD guidance. (A, I)
Ability to interpret new regulatory concepts and to apply to existing and future regulatory frameworks. (A, I)
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
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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.
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:
Leadership
Working Together
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
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 for more information on appropriate and inappropriate use.
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: 31st May 2026
Shortlisting date: from 1st June 2026
Interview date: week commencing 8th June 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
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 careers@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
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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.
