Overview

We are currently looking for a Diagnostics Assessor to join the 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 at 10 South Colonnade, Canary Wharf London, E14 4PU. Please note the role can only be worked in the UK and not overseas. A hybrid working pattern is in place with a minimum of 8 days per month on site to enable collaboration with partners and stakeholders, which may flex up to 12 days a month depending on business needs.

We are implementing a flexible, hybrid way of working with attendance driven by business needs. Some roles may require more on-site presence.

Who we are

The Medicines and Healthcare products Regulatory Agency enhances and improves 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.

Role details

You will lead the review and approval of In Vitro Diagnostics when used in clinical trials for medicines and support the continued development and implementation of Diagnostics and Medical Device regulations. You will also support engagement and partnership 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 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, and to review all applications for clinical trials where there is an IVD / companion diagnostic component.

Responsibilities

• Review all applications for clinical trials with 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.

Qualifications and experience

• 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, with ability to convey technical information to various stakeholders.
• Successful candidates must undergo a criminal record check.
• Personnel security standard checks are required for government assets.

Salary and benefits

Salary: £58,983 plus £17,087 towards Civil Service Defined Benefit Pension scheme. Benefits include:

• Annual leave: 25 days on entry, rising to 30 days with length of service, plus 8 bank holidays (pro-rata for part-time).
• Privilege Leave: 1 day.
• Hours of Work: 37 hours per week (full time), pro-rata for part-time staff.
• Occupational Sick Pay: up to five months full pay/five months half pay depending on service length.
• Mobility across the Civil Service.
• Flexible working arrangements and access to various employee benefits and development opportunities.

Additional information

Closing date: 28 September 2025. Shortlisting: w/c 29 September 2025. Interviews: 13 and 14 October 2025. Applicants will be contacted within a week after the sift and interviews. If you require disability-related adjustments at any point during the process, please contact careers@mhra.gov.uk. Applicants must meet UK immigration and Civil Service nationality rules.

Diversity and inclusion

The Civil Service Code and merit-based recruitment principles apply. The Civil Service embraces diversity and promotes equal opportunities. We support disability inclusion and offer various schemes to assist candidates with disabilities.

Nationality and security statements

Nationality requirements and security checks are described in the job description. Some roles may require vaccinations or health surveillance, especially laboratory-based or travel-related positions.