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 Borderline Adviser to join our Authorisation Lifecycle Function within the Health 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.
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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
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 Authorisation Lifecycle function is an enabler, central to delivery of the frontline HQA group. It includes data assurance and quality, high-volume certification work and coordination and support to the frontline functions. It also includes some more complex activity that supports across the product lifecycle such as medicines and medical devices, borderline, patient information and medicines advertising.
What’s the role?
The role of a Borderline Adviser is to assist in the determination of whether a specified product falls within the definition of a ‘medicinal product’ or a ‘medical device’, and the appropriate legal risk classification in the case of medical devices by researching and providing relevant material to Borderline Leads.
The role requires engaging with industry, other regulators, legal services and industry stakeholders to communicate the Agency’s policy in respect of borderline products and decisions made.
The area of Borderlines is a highly varied and innovative sector at a time of much transition and change. The post holder will also have some engagement and interact with the team developing the future regulatory framework for medical devices, IVDs and software.
Key responsibilities:
- To assist in determining whether products fall within the legal definition of a medicinal product and take appropriate action to bring these into compliance with medicines legislation.
- To assist determining whether a product falls within the legal definition of a medical device and its appropriate risk classification, and support Devices Compliance team in taking action to bring products into compliance with medical device legislation.
- Develop an understanding of the regulatory areas which border with medicinal products or medical devices and the impact of case law which influences the way borderline products are classified.
Triage enquiries and complaints received into the Borderline inbox, allocate complex and urgent requests to SEOs, and create in Sharepoint for non-urgent cases, sending acknowledgements where required.
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Who are we looking for?
Our successful candidate will demonstrate the following:
Excellent communicator; verbal, written and presentational which can be deployed to effectively represent the Agency at all levels including external UK, and international fora.
Sound interpersonal skills. Proven ability to proactively build relationships and work successfully in a multidisciplinary team environment.
Proven ability to gather, interpret and analyse the information necessary for decisions on the status of products.
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Person Specification:
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
Experience Criteria:
Proven ability to gather, interpret and analyse the information necessary for decisions on the status of products. (A,I)
Ability to identify important/key points from often complex documents and apply legal principles, precedents etc. to casework. (A,,I)
Technical Criteria:
Degree in a life science / nutrition subject area or substantial experience in a relevant regulatory role. (A)
A working knowledge of medicines, medical device, food, cosmetics or advertising regulations. (A,I)
An interest and awareness of issues affecting and impacting on the regulation of healthcare products is also desirable. (A,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: A working knowledge of medicines, medical device, food, cosmetics or advertising regulations.
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.
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 our candidate guidance for more information on appropriate and inappropriate use.
If you require any disability related adjustments at any point during the process, please contact [email protected] as soon as possible.
Closing date: 21 st June 2026
Shortlisting date: from 29 th June 2026
Interview date: from 7 th July 2026
If you need assistance applying for this role or have any other questions, please contact [email protected]
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 .
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 .
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 [email protected] .
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 [email protected]
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
[email protected]
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