Regulatory Affairs Lead - Audit at Medicines and Healthcare Regulatory Agency

, , United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

0.0

Posted On

04 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Device Regulation, Audit Planning, Regulatory Advice, CAPA Reviews, Quality Management Systems, Risk Management, Medical Device Vigilance, Complaint Handling, Regulatory Reporting, Stakeholder Communication, Problem Solving, Technical Documentation Review

Industry

Government Administration

Description

We are currently looking for a Regulatory Affairs Lead – Audit to join our Standards & Compliance Function within the Health Quality and Access group. This is a full-time opportunity, on a permanent basis. The role is a homebased role but will require occasional travel to 10 South Colonnade, Canary Wharf London, E14 4PU and South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas. 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 objective of the Healthcare Quality and Access Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. The Standards & Compliance function enables innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Inspectorate, the Inspection Action Group and Devices Audit and Compliance. What’s the role? This role is primarily responsible for providing regulatory support to the Agency’s proactive Market Surveillance and Approved Body Team. The post holder will be responsible for supporting senior management with the planning and coordination of MHRA’s proactive Market Surveillance plan which includes direct audits of medical device manufacturers (including economic operators) and review of technical documentation together with the development and delivery of the Approved Bodies plan. Key responsibilities: * Supporting and participating in audit planning and preparation * Providing clear, well-reasoned regulatory advice on implementation and interpretation of current and future UK medical device regulations * Supporting campaigns that feed into MHRA’s Approved Bodies and Post Market Surveillance Plans * Monitoring compliance through CAPA reviews and ensuring appropriate follow-up actions are taken Who are we looking for? Our successful candidate will demonstrate the following: * Knowledge and experience of the Medical Device Regulation * Communicating and Influencing * Making Effective Decisions and Problem Solver * Working Together * Understanding of Quality Management Systems and audit principles Person Specification: Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria: * Communicating & Influencing (A,I,P) * Working Together (I) * Making Effective Decisions (I) Experience Criteria: * Knowledge and experience of the Medical Device Regulations, medical device vigilance, complaint handling, risk management, and regulatory reporting (A,P) * Proven ability to understand and assess the impact of policy and regulatory changes, demonstrate the ability to quickly understand new or evolving policy and regulatory requirements and apply them to audit activities under guidance. You will be able to analyse how changes in legislation, standards, and MHRA processes may affect regulated organisations and audit priorities. (A,I) * Understanding of Quality Management Systems and audit principles; ideally with a Lead Auditor qualification. (A,I) Technical Criteria: * University degree in a relevant scientific, engineering, or technical discipline or equivalent knowledge / experience gained in the industrial arena and ability to demonstrate capability. (A) * Professional experience, which may include quality management, design, manufacture, testing, auditing, or use of medical devices or IVDs (A,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/ZOzkkUQMONstypdt] 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. * Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage. * 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: Knowledge and experience of the Medical Device Regulations, medical device vigilance, complaint handling, risk management, and regulatory reporting 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: 13th June 2026 Shortlisting date: from 15th June 2026 Interview date: week commencing: 6th July 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

Provide regulatory support for proactive Market Surveillance and Approved Body plans, including direct audits of medical device manufacturers. Responsible for reviewing technical documentation and monitoring compliance through CAPA reviews.