Innovative Devices Regulation Lead

Job Description
This vacancy is open to all Civil Service employees and employees of accredited non-departmental public bodies (NDPBs) who were appointed on merit following a fair and open competition; or were appointed to a permanent post through an exception in the Civil Service Commissioners' rules.
We are currently looking for a
Innovative Devices Regulation Lead
to join our
Innovative Devices
Function
within the
Healthcare Quality and Access
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. 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 objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.

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.

What's the role?
You will contribute and support senior colleagues on the development and implementation of Medical Device 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 Medical Devices.

You will work collaboratively in a matrix model with the safety and surveillance team to establish processes for - handling enquiries on Medical Devices on the UK market to ensure patient safety.

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

Key Responsibilities

• Contribute to the development and implementation of Medical Device Regulations as part of the broader MedTech Regulatory Reform programme, focusing on access to safer and more effective medical devices
• Lead frequent engagement with stakeholders, internally and externally, on all matters affecting regulatory policy and strategy development for Medical Devices.
• Establishing effective mechanisms for enquiry handling for medical devices on the UK market.
• Organise the continuous improvement in ways of working within the team, such as through optimising documentation processing, creating SOPs and templates, enabling automatic processes.

Who are we looking for?
Our Successful Candidate Will
Communicating and influencing
: Proven ability to communicate (written and oral) effectively to maintain positive working relationships with stakeholders.

Managing a Quality Service
- Experience of a flexible and adaptable attitude towards work, providing a proactive service and the ability to use initiative, foresight, and have a willingness to go the 'extra mile' and excellent attention to detail.

Experience
-Previous experience in IVD or a medical device regulatory area,including in a clinical, commercial, academic or policy setting. Experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs

Essential

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

Desirable

• A Masters, PhD or equivalent in a scientific, engineering or medical discipline.
• Knowledge of current UK MDR and EU IVDR, understanding of the methodological approaches used to demonstrate IVD performance.*insert 5 civil service success profiles here excl. ability and strengths*

Person Specification
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria
Communicating & influencing
(A, I)
Managing a Quality Service
(A, I)
Delivering at Pace
(A, I)
Experience Criteria

• Previous experience in IVD or medical device regulatory area, including in a clinical, commercial, academic or policy setting. (A, I)
• Experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs. (A, I)

Desirable Criteria -
Experience of developing, evaluating (including analytical validation, clinical studies and trials, or systematic reviews and evidence synthesis) and/or policy development.
(A, I)
Technical Criteria
Bachelor's degree of equivalent in scientific, engineering or medical discipline
(A)
Desirable Criteria -
A Masters, PhD or equivalent in a scientific, engineering or medical discipline. Knowledge of current UK MDR and EU IVDR, understanding of the methodological approaches used to demonstrate IVD performance.
(A)
Strengths Criteria

• Problem Solver (I)
• Adaptable (I)

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 candidates, find out more here .

• 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. 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 the Behaviour, 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 candidates demonstrating
experience in IVD or medical device regulatory area, including in a clinical, commercial, academic or policy setting. Experience developed through previous roles in Regulatory Affairs, Quality Assurance or Medical Affairs.
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 allow sufficient time. You can view the competencies for this role in the job description.

If you require any disability related adjustments at any point during the process, please contact

as soon as possible.
Closing date: 18 th December 2025

Shortlisting date: from 19th December 2025

Interview date: from 5 th January 2026

If you need assistance applying for this role or have any other questions, please contact

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 .

Role
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 .

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 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 firstly contact Florentina Oleylami, 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

1 Horse Guards Road

London

SW1A 2HQ

About Us
ABOUT US
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 agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.

The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.