Innovative Devices Delivery Lead at Medicines and Healthcare Regulatory Agency

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

02 Jun, 26

Salary

0.0

Posted On

04 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Programme Management, Policy Development, Regulatory Frameworks, Software As A Medical Device (SaMD), Artificial Intelligence (AI) Governance, Stakeholder Engagement, Risk Management, Timeline Management, Governance, Cross-functional Coordination, Negotiation, Attention To Detail, Written Communication, Adaptability, Analytical Skills

Industry

Government Administration

Description

We are currently looking for an Innovative Devices Delivery Lead to join our Innovative DevicesTeam/Function Innovation and Compliance group. This is a full-time opportunity, on a permanent 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 Innovative Devices function is leading on the development of a new regulatory framework for the UK, which protects patient safety whilst enabling innovation. It also works to improve pre-market support for medical device manufacturers and developers and facilitate a smooth passage to market access through improved regulation and guidance along with tailored support for innovative products across med-tech, diagnostics and digital, or where there is higher associated risk. The function will ensure that the UK has supply of new and advancing medical devices to include software as a medical device, novel implantable devices and diagnostics. What’s the role? The role is a full-time, permanent position. The primary purpose of this role is to provide programme and project management support to the secretariat of the National Commission into the Regulation of AI in Healthcare, the MHRA Software and AI team, and the wider Innovative Devices team. The role will be responsible for ensuring the rapid delivery of policy commissions, coordinating across policy and operational teams, creating and maintaining project and programme planning tools, and managing stakeholder engagement both within and outside of the Agency. The post holder will be familiar with the regulation of software and AI as medical devices and the application of software and AI tools to the delivery of healthcare. They will support the software and AI team to work across the MHRA, other UK government departments, academia, healthcare providers, and international regulatory partners to shape and implement a robust and future-proof regulatory framework for software and AI medical devices. The post holder will also work closely with the MedTech Reform Delivery Lead to deliver a programme management function across the Innovative Devices function that will support the development and delivery of ongoing reform to the UK’s medical devices regulations. This is an exciting time to join the Innovative Devices group to support the Software and AI regulation and policy team at the MHRA, as we work to deliver the National Commission on the regulation of AI in healthcare, 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: AI Commission Delivery Lead * Lead end-to-end delivery of AI policy commissions, providing strategic oversight from initiation through to implementation. * Own delivery planning and governance, including timeline management, risk and dependency tracking, and proactive identification and resolution of delivery blockers. * Act as a central coordination point across multidisciplinary teams (policy, technical, legal, analytical), ensuring alignment and momentum against strategic objectives. * Manage senior stakeholder engagement, balancing policy intent, delivery constraints, and external considerations to drive successful outcomes. * Provide cross-cutting programme and project support across software and AI portfolios, identifying emerging delivery needs and tailoring support accordingly. * Support complex, often novel, digital and AI initiatives, including engagement with international partners and stakeholders to share best practice and align approaches. * Contribute to the development of funding bids and grant applications, including drafting proposals and supporting business cases. * Support workforce growth and capability through leading the recruitment processes, including role scoping, shortlisting, and interview panels. * Work closely with the MedTech Regulatory Reform Delivery Lead to support delivery of priority reform programmes. * Contribute to project planning, coordination, and tracking across regulatory reform workstreams, supporting delivery against strategic timelines. * Support collaboration across policy, regulatory, and delivery teams to ensure reforms are practical, coherent, and deliverable. Wider Software and AI Programme Support * Provide cross-cutting programme and project support across software and AI portfolios, identifying emerging delivery needs and tailoring support accordingly. * Support complex, often novel, digital and AI initiatives, including engagement with international partners and stakeholders to share best practice and align approaches. * Contribute to the development of funding bids and grant applications, including drafting proposals and supporting business cases. * Support workforce growth and capability through leading the recruitment processes, including role scoping, shortlisting, and interview panels. Medical Technology Regulatory Reform Support * Work closely with the MedTech Regulatory Reform Delivery Lead to support delivery of priority reform programmes. * Contribute to project planning, coordination, and tracking across regulatory reform workstreams, supporting delivery against strategic timelines. * Support collaboration across policy, regulatory, and delivery teams to ensure reforms are practical, coherent, and deliverable. Who are we looking for? Our successful candidate will demonstrate the following. * Demonstrate significant working experience in project managing a policy, regulatory, technology-based team. Experience of working with complex information which could include regulation, policy development, legislation. * Experience of project and programme management on AI governance or policy * 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 * Strong interpersonal skills, including the ability to negotiate and maintain good relationships with senior officials in assigned stakeholder areas. * Ability to work as a member of a project team to deliver defined objectives under tight deadlines. Person Specification: Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria: * Communicating and influencing: Communicate in a straightforward, honest and engaging manner, choosing appropriate styles to maximise understanding and impact. Encourage the use of different communication methods, including digital resources and highlight the benefits, including ensuring cost effectiveness (A,I) * Leadership: Consider the impacts of own and team’s activities on stakeholders and end users. ·(A,I) * Delivering at pace: Act promptly to reassess workloads and priorities when there are conflicting demands to maintain performance. Allow individuals the space and authority to meet objectives, providing additional support where necessary, whilst keeping overall responsibility. (A,I) Experience Criteria: * Experience of project managing complex programmes with multiple external partners and organisations (A,I) * Experience of working in a medical field an advantage (A,I) * Experience of leading delivery of projects focused on the regulation of medical devices and software and AI as a medical device (A,I) Technical Criteria: * Excellent written and oral communication skills including grammatical/technical writing skills, and an ability to simplify complex technical issues for non-specialist audiences at executive level. (A,I) * Excellent attention to detail and accuracy. (A,I) Strengths Criteria * Adaptable: You can adapt to variations in work or environment, and your effectiveness isn’t impacted by change. You are flexible and versatile and act as an advocate for change (I) * Analytical: You seek and analyse information to inform decisions based on the best available evidence · (I) * Problem Solver: You take a positive approach to tackling problems and find ways to identify suitable solutions. (I) If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! [https://mhra-gov.filecamp.com/s/d/jWaLXAX3XvopUOlp] 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 [careers@mhra.gov.uk] The selection process: We use the Civil Service Success Profiles to assess our candidates, find out more here [https://www.gov.uk/government/publications/success-profiles]. * Online application form, including a statement of suitability, attached as a PDF of no more than 1000 words demonstrating how you meet the person specification. 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. Please ensure not to include any personal identifying information on your supporting information. * 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 demonstrating their experience of leading delivery of projects focused on the regulation of medical devices and software and AI as a medical device. 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 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 [https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.civil-service-careers.gov.uk%2Fartificial-intelligence-and-recruitment%2F&data=05%7C02%7CUfuoma.Eriemo2%40mhra.gov.uk%7C3d175bf263f54c3cf85608de3bfa288f%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C639014142773052769%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2VE8qZPdzo8azEL775DBoKUPz5zMHopZPjc9cs3KuOk%3D&reserved=0]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 [careers@mhra.gov.uk] as soon as possible. Closing date: 10th March 2026 Shortlisting date: from 11th March 2026 Interview date: from 17th March 2026 If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk [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 [https://www.gov.uk/government/publications/nationality-rules]. 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 [https://www.gov.uk/government/publications/government-baseline-personnel-security-standard?_ga=2.149328757.2118900794.1613132232-433185063.1580991281]. 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 [https://www.childcarechoices.gov.uk/]. 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 [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 [https://civilservicecommission.independent.gov.uk/] info@csc.gov.uk [info@csc.gov.uk] Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ 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.

Responsibilities

The primary purpose of this role is to provide programme and project management support to the secretariat of the National Commission into the Regulation of AI in Healthcare and the wider Innovative Devices team, ensuring the rapid delivery of policy commissions and coordinating across various teams.