Medicines and Healthcare products Regulatory Agency
IVD Assessor
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We are currently looking for two IVD Assessors to join our Clinical Investigations Function within the Scientific Research and Innovation 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. 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 Clinical Investigations and Trials function provides efficient, pragmatic, proportionate and patient-centred advice for, and assessment of, Clinical Investigations into the performance and safety of medical devices and diagnostics as well as Clinical Trials of investigational medicinal products.
What’s the role?
The post holder will lead the review and approval of In Vitro Diagnostics where they are used in clinical trials for medicines and support the continued development and implementation of Diagnostics and Medical Device regulations.
Key responsibilities:
- Review all applications for clinical trials where there is an IVD / companion diagnostic component.
- Liaise with the head of clinical trials and clinical investigations and their respective teams.
- Provide scientific and technical capacity to inform regulatory decision making.
- Provide scientific and technical input towards use cases in partnership with stakeholders as required.
Who are we looking for?
Our successful candidate will have:
- A degree or equivalent in a relevant discipline e.g. Biochemistry, medicine.
- Experience in IVD policy, product development or conformity assessment.
- Experience working in a clinical, medical or toxicology laboratory.
- Prior experience with manufacturing and/or research and development of an IVD medical device.
- Expert understanding of UK MDR, EU IVDR and EU MDR, Clinical trial regulations, particularly clinical evidence for IVD medical device.
Person Specification:
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
- Communicating and Influencing (A, I)
- Leadership (A, I)
- Delivering at Pace (A, I)
Experience Criteria:
- Extensive experience and knowledge of the IVD Directives, EU IVDR and awareness of the UK Clinical Trials regulations and UK MDR (2002) (Part IV) (A, I)
- Substantial experience in policy, advisory or product development (A, I)
- Substantial experience of working in a clinical, medical or toxicology laboratory (A, I)
- Prior experience with manufacturing and/or research and development of a medical device (A, I)
- Experience leading technical aspects of regulatory or clinical affairs (A, I)
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Technical Criteria:
- Minimum Master's degree in a relevant discipline e.g., biochemistry, biomedical engineering, medicine. A PhD in a relevant discipline is desirable (A)
- Excellent verbal and written communication skills, and ability to communicate technical information to various stakeholders
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/static/files/OILpzOieoomT2LaO.pdf]!
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.
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 Substantial experience in policy, advisory or product development.
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.
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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: 19th July 2026
Shortlisting date: from 24th July 2026
Interview date: from 3rd August 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 [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 [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
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