Benefit Risk Evaluation Assessor - Software

We are currently looking for a Benefit Risk Evaluation Assessor Softwareto join our Benefit Risk Evaluation I Team within the Safety & Surveillancegroup.

This is a full-timeopportunity 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 Safety and Surveillance (S&S) Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agencys data and evidence generating capabilities complementing our signal generating abilities.

Against this background and the drive to improve treatment availability for patients safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying assessing and managing the risks associated with medical every aspect of this work we harness the best science technology information and professional practice to protect patients in new and impactful ways.

The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical scientific clinical and regulatory knowledge and practical experience. The team conducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The team is responsible for:

• Ensuring a world class comprehensive vigilance system that can promptly detect and monitor signals across the product life cycle

• Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures

• Exploiting data and embracing new technologies to develop the evidence to support our actions and understand their impact

Whats the role

We have available two exciting opportunities within the Benefit-Risk Evaluation group a critical component of Safety and Surveillance. Reporting to the Biosafety Nonclinical and Emerging Technologies TAU Head the assessor will provide technical and regulatory expertise and leadership on software as a medical device to the Benefit Risk Evaluation Group the Software and AI Group and across the wider MHRA. The post holders are required to use a range of data sources to undertake trending activities and identify safety signals for further investigation. Additionally post holders will also contribute to the development of the regulatory framework for software as a medical device.

Key responsibilities:

• Actively participate in meetings and work programmes to assess safety signals involving software as medical devices; effective management of trending activities and safety signal reports ensuring cases are kept up-to-date and quality of work is maintained.

• Provide specialist technical advice and support on software as a medical device to other colleagues and senior officials to meet divisional business needs and targets.

• Undertake technical reviews of software as a medical device as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients.

• Develop and implement regulatory changes on software as a medical device through legislative reform and clarificatory guidance and provide advice and guidance to stakeholders as this evolves.

Who are we looking for

Oursuccessful candidatewill have:

• Degree or equivalent qualification in a health care regulatory or health data science/analytics (such as medical engineering material science or healthcare qualification); and/or Previous relevant experience gained in healthcare medical device manufacturing regulatory environment or health data science.

• Technical knowledge or practical experience of a range of software medical devices is preferable.

• Experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear. Implement appropriate actions to mitigate risk

• Evidence of writing well-structured concise authoritative reports to support decision making on drug / device safety and provide technically sound information to stakeholders.

• Sharing knowledge to improve patient safety

If you would like to find out more about this fantastic opportunity please read our Job Description and Person Specification!

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The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

• Online application form including questions based on theBehaviour 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 theBehaviour 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: Technical knowledge or practical experience of a range of software medical devices.

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 as soon as possible.

Closing date:31 August 2025

Shortlisting date: w/c 01 September 2025

Interview date: w/c 15 September 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 questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

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 completebasic 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 applicants 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 eligibilityhere.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit 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.

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ