Innovative Devices Regulation Lead

Get AI-powered advice on this job and more exclusive features. About Us The Medicines and Healthcare products Regulatory Agency (MHRA) enhances and improves the health of millions of people every day through effective regulation of medicines and medical devices, underpinned by science and research. The agency is made up of approximately 1,300 staff working across two main centres and peripatetically across the UK and abroad. It consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation. Role Overview We are looking for an Innovative Devices Regulation Lead to join our Innovative Devices Function within the Healthcare Quality and Access group. The role is full‑time, permanent and based at 10 South Colonnade, Canary Wharf, London, E14 4PU. It can only be worked from the UK. Our office is adopting a flexible, hybrid model. Employees are expected to work at least 8 days per month on site, with the option to increase to 12 days depending on business needs. Key Responsibilities Contribute to the development and implementation of Medical Device Regulations as part of the broader MedTech Regulatory Reform programme, focusing on access to safer and more effective medical devices. Lead frequent engagement with stakeholders, internally and externally, on all matters affecting regulatory policy and strategy development for Medical Devices. Establish effective mechanisms for enquiry handling of medical devices on the UK market. Organise continuous improvement in ways of working within the team, such as optimising documentation processing, creating SOPs and templates, and enabling automated processes. Qualifications Communicating and influencing: Proven ability to communicate (written and oral) effectively to maintain positive working relationships with stakeholders. Managing a Quality Service: Demonstrates a flexible and adaptable attitude towards work, providing a proactive service and using initiative, foresight, and a willingness to go the ‘extra mile’, with excellent attention to detail. Experience: Previous experience in IVD or a medical device regulatory area, including in a clinical, commercial, academic or policy setting. Experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs. Technical: Essential Bachelor’s degree of equivalent in a scientific, engineering or medical discipline. Desirable A Masters, PhD or equivalent in a scientific, engineering or medical discipline. Knowledge of current UK MDR and EU IVDR, and understanding of the methodological approaches used to demonstrate IVD performance. Insert 5 civil service success profiles here excluding ability and strengths. Person Specification Behaviour Criteria Communicating & Influencing (A, I) Managing a Quality Service (A, I) Delivering at Pace (A, I) Experience Criteria Previous experience in IVD or medical device regulatory area, including in a clinical, commercial, academic or policy setting (A, I). Experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs (A, I). Desirable Criteria Experience of developing, evaluating (including analytical validation, clinical studies and trials, or systematic reviews and evidence synthesis) and/or policy development (A, I). Technical Criteria Bachelor’s degree of equivalent in scientific, engineering or medical discipline (A). Strengths Criteria Problem Solver (I) Adaptable (I) Application Process Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; incomplete responses may lead to the application not being considered. Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles. Important Dates Closing date: 18 th December 2025 Shortlisting date: from 19th December 2025 Interview date: from 5th January 2026 Additional Information Applicants who are successful at interview will be subject to pre‑employment screening, including a check on the Internal Fraud Database (IFD). 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 fraud. Certain MHRA roles may require vaccinations and routine health surveillance, particularly for laboratory or overseas travel roles. Successful candidates must pass a disclosure and barring security check as well as animal rights and pro‑life activism checks. If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible. For more information on how we recruit and select, and for any complaints about the process, you may contact Head of Talent Acquisition, Florentina Oyelami at Florentina.Oyelami@mhra.gov.uk or the Civil Service Commission at civilservicecommission.independent.gov.uk. Additional contact for EEO compliance: info@csc.gov.uk. #J-18808-Ljbffr