Devices Regulatory Specialist

We are currently looking for aDevices Regulatory Specialist to join ourInnovative Devices Function within theInnovation and Compliance Group.

Please note this opportunity is currently only available to those working within the Civil Service. Applications from non-Civil Servants may not be reviewed and may be rejected.

This is a full-time opportunity 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.We are open to requests for flexible working. Please discuss this with the recruiting manager before accepting an appointment.

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 Innovation and Compliance Group delivers public health impact world-leading innovation and a unique proposition which will balance innovation with sustainability and regulatory compliance. 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 consists of the Diagnostics and General Medical Devices team and Software/AI teams. It is the function that provides pre-market support and smooth passage to market access for innovative medical devices and to play a significant role in developing the new regulatory framework.The 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.

Whats the role

The successful candidate 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 Agency and liaising with senior external stakeholders both in the UK and internationally.

The post holder 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:

• Take ownership of the delivery of discrete aspects of the new regulatory regime for medical devices as directed by the Analysis and Reporting Lead. This includes providing input into any future legislation and implementation (e.g. service delivery of regulatory advice) including Parliamentary briefings and support for Parliamentary debates.

• Work with experts across the Agency the Department of Health and Social Care Government Legal Department and 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 patient groups and healthcare professionals.

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

Who are we looking for

Oursuccessful candidatewill:

• Be educated to at least Bachelors degree level

• Have a working knowledge of UK and EU medical devices legislation

• Be experienced in developing policy and legislation

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

• Have strong written communication skills and are able to draft a range of policy and guidance documents for different audiences

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 ofcandidates having a thorough understanding of the UK Medical Devices Regulations 2002 EU MDR and EU IVDR.

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

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:17^th August 2025

Shortlisting date: 19^th August 2025

Interview date:29^th August 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.

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 OleylamiHead 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