Diagnostics Assessor

We are currently looking for a Diagnostics Assessor to join Clinical Investigations and Trials function within the Science, Research & Innovation group.

This opportunity is available either full time or part time, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.  

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 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?

You 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. You will also support key engagement and partnership working with key senior external stakeholders, government departments, professional bodies and the wider health sector to ensure UK patients have access to safe and effective innovative Diagnostics.

The post holder will also, when required, work collaboratively in a matrix model with the Diagnostics Safety and Surveillance and Science and Research functions, providing scientific and technical input as required to enhance product safety and effectiveness as well as assessing applications.

You may be required to provide input into the investigation of safety issues arising from device related adverse incidents and trending activities.

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.
• Provide scientific and technical input to independent expert advisory committees as required.
• Lead in data analysis for identifying trends and making recommendations for action.
• Adapt and apply knowledge in implementing world leading regulations.

Who are we looking for? 

Our Successful Candidate Will Have:

• Minimum Master's degree in a relevant discipline e.g., biochemistry, biomedical engineering, medicine 
• Substantial experience in IVD policy, product development or conformity assessment 
• Substantial experience working in a clinical, medical or toxicology laboratory. 
• Prior experience with manufacturing and/or research and development of an IVD medical device. 
• 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! 

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. 

• 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 Communicating and Influencing. 

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

Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own.

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: 28 September 2025
• Shortlisting date: W/C 29 September 2025
• Interview date: 13 and 14 October 2025

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.

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. 

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.

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.

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.

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 Florentina Oyelami, Head of Talent Acquisition – Florentina.Oyelami@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 

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.