Diagnostics Lead - £47,776 - £53,474 p.a. + benefits

Job summary

We are currently looking for a Diagnostics Lead to join our Innovative Devices Functionwithin the Innovation & Compliance 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

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.

Innovation and Compliance (I&C) group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which balances innovation against sustainability and affordability. It is divided into four sub-groups: Innovation Accelerator and Regulatory Science, Clinical Investigations and Trials, Standards and Compliance and Innovative Devices.

The Innovative Devices function includes the Diagnostics and General Medical Devices team and Software/AI teams. Our teams collaborate closely to drive regulatory reform for medical devices and in vitro diagnostics (IVD) devices, including software and AI, ensuring access to high-quality, safe, and effective devices.

The Diagnostics team focuses on delivering regulations for IVD devices which can include policies that cover other types of medical devices. We conduct stakeholder engagement and public consultations, respond to ministerial enquiries on aspects of IVD regulation in the UK, and contribute to safety and surveillance of IVD devices on market.

Job description

Role Purpose

You will contribute and support senior colleagues on the development and implementation of IVD Regulations as part of the wider MedTech Regulatory Reform.

You will support engagement and partnerships with key internal and external stakeholders, including other government departments, professional bodies, trade associations and the wider health sector to ensure UK patients have access to safe and effective innovative IVDs.

You will work collaboratively in a matrix model with the safety and surveillance team to establish processes for collecting and analysing safety signals of IVDs on the UK market to ensure patient safety.

You will actively contribute towards ongoing improvement and a positive working environment within the Diagnostics team and throughout the wider Agency.

Key Responsibilities

Regulations and policy:

• Contribute to the development and implementation of IVD Regulations as part of the broader MedTech Regulatory Reform programme, focusing on access to safer and more effective IVD devices.
• Lead the scientific and technical capability of the team to inform regulatory decision making, as well as providing input into guidance and standards development. This includes regulations implementations.
• Lead the delivery of aspects of the new IVD regulatory regime with support from senior colleagues.
• Support senior colleagues on the delivery of new Diagnostics legislation, including policy development, ministerial submissions, parliamentary debates, impact analysis and communication plans.

Communication and partnership:

• Lead frequent engagement with stakeholders, internally and externally, on all matters affecting regulatory policy and strategy development for Diagnostics.
• Contribute to maintaining effective communication across the agency, as well as responding to enquiries from external stakeholders, including the public, academics, industry, and trade associations.
• Support the establishment of partnerships with key external stakeholders such as patients and the public, NICE, National External Quality Assurance Schemes (NEQAS), Royal College of Pathologists and emerging health organisations.
• Coordinate the effective liaison with key stakeholders on all issues affecting regulatory policy to help ensure that stakeholder views are represented in policy decisions.

Safety and surveillance:

• In collaboration with the Safety and Surveillance team, contribute to establishing effective mechanisms for collecting and analysing safety signals of IVD devices on the UK market.

Process improvement:

• Organise the continuous improvement in ways of working within the team, such as through optimising documentation processing, creating SOPs and templates, enabling automatic processes.

The job description is not intended to be exhaustive, and it is likely that responsibilities and outcomes may be altered from time to time in the light of changing circumstances and after consultation with the postholder.

Person specification

Essential Criteria:

• Essential: Previous experience in IVD or a similar regulatory area, for example medical devices, including in a clinical, commercial, academic or policy setting. Experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs.
• Desirable: Experience of developing, evaluating (including analytical validation, clinical studies and trials, or systematic reviews and evidence synthesis) and/or policy development.

Qualifications

Bachelor’s degree of equivalent in a scientific, engineering or medical discipline

Behaviours

We'll assess you against these behaviours during the selection process:

• Seeing the Big Picture
• Changing and Improving
• Communicating and Influencing
• Delivering at Pace

Technical skills

We'll assess you against these technical skills during the selection process:

• Bachelor’s degree of equivalent in a scientific, engineering or medical discipline (Essential)
• A Masters, PhD or equivalent in a scientific, engineering or medical discipline (Desirable).
• Knowledge of current UK MDR and EU IVDR, understanding of the methodological approaches used to demonstrate IVD performance (Desirable)

Benefits

Alongside your salary of £47,776, Medicines and Healthcare Products Regulatory Agency contributes £13,840 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of six months full pay and six months half pay after five years’ service.
• Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
• Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666
• Flexible working to ensure staff maintain a healthy work-life balance
• Interest free season ticket loan or bike loan
• Employee Assistance Services and access to the Civil Service Benevolent Fund
• Eligibility to join Motoring , Boundless by CSMA
• Variety of staff and Civil Service clubs
• On-going learning and development

Things you need to know

Artificial intelligence

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 (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours, Strengths, Experience and Technical skills.

Key dates

• Closing date 08 November 2026
• Sifting – From 09 November 2026
• Main panel interviews – From 02 December - 11 December 2026

Communications will be electronic via email therefore it is important that you check your Civil Service Jobs account regularly, as well as your spam/junk email folder.

We’re committed to being diverse and inclusive, so please make your application anonymous by removing all identifying personal information (such as names and dates) from your employment history and personal statement.

1. Sift Stage

• Anonymised CV which sets out your career history, previous experience and skills, highlighting specific responsibilities that are relevant for this role.
• 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

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of: Delivering at Pace.

The panel will look at your application and are looking for evidence of the stated points. We may raise the benchmark score required if we receive a high number of applications.

2. Main Panel Interview

Successful candidates from the sift stage will be invited to attend an interview. We use a blended interview technique, allowing us to find out more about you. We use the Success Profile framework and at interview we will be assessing Behaviours and Experience.

At interview, we will be asking questions relating to the following:

• Behaviours, as listed in the person specification
• Experience, as listed in the person specification
• Strengths

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

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.

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.

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a basic (or equivalent) criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

This vacancy is part of the Great Place to Work for Veterans (opens in a new window) initiative.Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : The Resourcing Team
• Email : Careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk

Further information

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 contact the Resourcing team at Careers@mhra.gov.uk, in the first instance. 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

Attachments

SEO Diagnostics Lead JD NS Opens in new window (pdf, 217kB)