Innovative Devices Regulation Lead

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

Oursuccessful candidatewill:

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

Technical-

Essential:

• Bachelors 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 hereexcl. ability and strengths*

Person Specification:

Method of assessment:AApplication TTest IInterview PPresentation

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:

Bachelors 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 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 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 allowsufficienttime. 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 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 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