Diagnostic Regulatory Specialist at Medicines and Healthcare Regulatory Agency

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

13 Oct, 26

Salary

0.0

Posted On

15 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Policy Development, Medical Device Legislation, Stakeholder Management, IVD Roadmap Delivery, Technical Writing, Leadership, International Regulatory Engagement, Scientific Analysis, Policy Drafting, Legislative Implementation

Industry

Government Administration

Description

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 Diagnostic Regulatory Specialist to join our Innovative Devices Function within the Health Quality and Access group. This is a full-time opportunity, on a fixed term contract until 31st March 2029, internal move, temporary promotion, loans will be considered. 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment. 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 Innovative Devices function works to provide pre-market support and facilitates a smooth passage to market access. This is particularly aimed at innovative products across MedTech, 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 implantables and diagnostics and play a significant role in developing the new regulatory framework for medical devices, including implementation and operation of specific services. What’s the role? With a focus on diagnostics, the postholder will support the continued development and implementation of the future regulatory framework for medical devices, leading on discrete areas and working in collaboration with colleagues within Innovative Devices and across the Agency, and liaising with senior external stakeholders, both in the UK and internationally. Leading a small team, the postholder will also contribute to the provision of expert regulatory advice to medical device and IVD device manufacturers. This is an excellent opportunity to be involved in a highly varied and innovative sector at a time of much transition and change and to play a hands-on role in delivering MHRA priorities. Key responsibilities: * Take ownership of delivering key elements of the new medical devices regulatory regime, including contributing scientific, technical and policy input to future legislation and implementation. Work with DHSC, Government Legal Department and partners to develop secondary legislation, and support Parliamentary briefings and debates to ensure delivery against key milestones. * Provide scientific, technical and policy input to support implementation of the regulatory framework through clear guidance and regulatory advice, ensuring outputs meet stakeholder needs and align with legislative requirements. * Oversee delivery of the in vitro Diagnostics (IVD) roadmap, tracking progress against milestones, coordinating input across teams, and ensuring alignment with wider regulatory plans. * Support international engagement with other regulators, including at the International Medical Devices Regulators Forum (IMDRF). Who are we looking for? Our successful candidate will demonstrate the following: * Minimum of a Bachelors degree or equivalent experience * Working knowledge of the UK and/or EU Medical Devices legislation * Experience of communicating with a range of stakeholders in the development and / or delivery of policy objectives * Experience of policy development in a regulatory environment with ability to draft a range of policy and guidance documents for different audiences Person Specification: Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria: * Leadership (A,I) * Communicating and Influencing (A,I) * Working Together (A,I) * Seeing the Big Picture (A,I) Experience Criteria: * Experience of policy development in a regulatory environment (A,I) * Working knowledge of the UK Medical Devices Regulations 2002, with knowledge of the EU Medical Devices Regulation and/or EU in vitro Diagnostic Medical Devices Regulation also desired. (A,I) Technical Criteria: * Minimum of a Bachelors degree or equivalent in a scientific, engineering or medical discipline - e.g. physics, chemistry, engineering, life sciences, pharmacy, nursing or medicine. Equivalent experience will be accepted in place of a degree. (A) 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/4W8g3AmtlrtcHmjl] 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 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 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 [https://eur01.safelinks.protection.outlook.com/?url=https://www.civil-service-careers.gov.uk/artificial-intelligence-and-recruitment/&data=05|02|Ufuoma.Eriemo2@mhra.gov.uk|3d175bf263f54c3cf85608de3bfa288f|e527ea5c62584cd2a27f8bd237ec4c26|0|0|639014142773052769|Unknown|TWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ==|0|||&sdata=2VE8qZPdzo8azEL775DBoKUPz5zMHopZPjc9cs3KuOk=&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: 31st July 2026 Shortlisting date: from 3rd August 2026 Interview date: from 31st August 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 postholder will lead the development and implementation of the future regulatory framework for medical devices and in vitro diagnostics. This includes providing expert regulatory advice to manufacturers and collaborating with international regulators and government departments.