Devices Regulatory Specialist

We are currently looking for aDevices Regulatory Specialistto join ourInnovative Devicesfunction within theInnovation and Compliancegroup.

This is a full-timeopportunity 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.

Who are we

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 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 works to provide pre-market support andfacilitatesa smooth passage to market access. This is particularly aimed at innovative products across MedTech diagnostics and digital or where there is higher associated risk. The function will ensure that the UK has supply of new and advancing medical devices to include software as a medical device novelimplantablesand diagnostics and play a significant role in developing the new regulatory framework for medical devices including implementation and operation of specific services.

Whats the role

The postholder will support the continued development and implementation of the future regulatory framework for medical devices leading on discrete areas and working in collaboration with colleagues within Innovative Devices and across the Agencyand liaising with senior external stakeholders both in the UK and postholder will also contribute to the provision of expert regulatory advice to medical device and IVD device manufacturers. This is an excellent opportunity to be involved in a highly varied and innovative sector at a time of much transition and change and to play a hands-on role in delivering MHRA priorities.

Key responsibilities:

• Takeownership of the delivery of discrete aspects of the new regulatory regime for medical devices as directed by theInnovative IVDs and General Medical Devices Lead. This includes providing input into any future legislation and implementation including Parliamentary briefings and support for debates and supportingservice delivery of regulatory advice.

• Work with experts across the Agency the Department of Health and Social Care Government LegalDepartmentand other key stakeholders to develop the required secondary legislation to deliver the future regulatory framework and ensure it meets the key milestones for delivery.

• Provide effective liaison with key stakeholders on all issues affecting regulatory policy and ensure that stakeholder views are represented in policy decisions. This includes engagement with key colleagues across the Agency the Department of Health and Social Care the Office of Life Sciences and our wider stakeholder network including Trade Associations patientgroupsand healthcare professionals.

• Support international engagement with other regulators including at the International Medical Devices Regulators Forum (IMDRF).

Who are we looking for

Oursuccessful candidatewill have the following:

• Educated to at leastBachelorsdegree level

• Working knowledge of UK and EU medical devices legislation

• Experience in developing policy and legislation

• Experience of communicating with a range of stakeholders in the development and / or delivery of policy objectives

• Strong written communication skills with ability todraft a range of policy and guidance documents for different audiences

Person Specification:

Method of assessment:AApplication IInterview

Behaviour Criteria:

• LEAD CRITERIA - Leadership a proven leader visible empowering others building resilience and leading improvements. Consider the impacts of own and teams activities on stakeholders and end users(A I)

• Communicating and Influencing communicate with others in a clear honest and enthusiastic way in order to build trust. Explain complex issues in a way that is easy to understand(A I)

• Working Together works effectively as part of a multi-disciplinary team to maintain positive working relationships working across boundaries and adding value through strategic thinking(A I)

• Seeing the Big Picture ensure plans and activities in your area of work reflect wider strategic priorities and communicate effectively with senior leaders to influence future strategies. Bring together views perspectives and diverse needs of stakeholders to gain a broader understanding of the issues surrounding policies and activities. (A I)

Experience Criteria:

• Experience of policy development in a regulatory environment(A I)

• Demonstrable experience of effective use of resources to meet agreed workload priorities and allocation of staff(A)

• Working knowledge of the UK Medical Devices Regulations 2002 with knowledge of the EU Medical Devices Regulation and/or EU in vitro Diagnostic Medical Devices Regulation also desired(A I)

Technical Criteria:

• Minimum of a Bachelors degree or equivalent in a scientific engineering or medical discipline - e.g. physics chemistry engineering life sciences pharmacy nursing or medicine. Equivalent experience will be accepted in place of a degree (A)

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.

• 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 ofLeadership a proven leader visible empowering others building resilience and leading improvements. Consider the impacts of own and teams activities on stakeholders and end users.

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 allowsufficienttime. 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 ourcandidate guidancefor more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:18 May 2026

Shortlisting date: w/c 18 May 2026

Interview date:w/c 08 June 2026

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.

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.

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

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