At a Glance
- Tasks: Lead the development of innovative medical device regulations and provide expert advice.
- Company: Join the Medicines and Healthcare products Regulatory Agency, enhancing public health.
- Benefits: Flexible hybrid working, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with international engagement and significant career advancement potential.
- Why this job: Make a real impact in healthcare by shaping the future of medical device regulations.
- Qualifications: Bachelor's degree or equivalent experience in a scientific or engineering discipline.
The predicted salary is between 55000 - 65000 £ per year.
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 Diagnostic Regulatory Specialist to join our Innovative Devices Function within the Health Quality and Access group. This is a full-time opportunity, on a fixed term contract until 31st March 2029. 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.
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 (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 and facilitates a smooth passage to market access. This is particularly aimed at innovative products across MedTech, diagnostics and digital, or where there is higher associated risk.
What’s the role? With a focus on diagnostics, 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 Agency, and liaising with senior external stakeholders, both in the UK and internationally. Leading a small team, the 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:
- Take ownership of delivering key elements of the new medical devices regulatory regime, including contributing scientific, technical and policy input to future legislation and implementation.
- Work with DHSC, Government Legal Department and partners to develop secondary legislation, and support Parliamentary briefings and debates to ensure delivery against key milestones.
- Provide scientific, technical and policy input to support implementation of the regulatory framework through clear guidance and regulatory advice, ensuring outputs meet stakeholder needs and align with legislative requirements.
- Oversee delivery of the in vitro Diagnostics (IVD) roadmap, tracking progress against milestones, coordinating input across teams, and ensuring alignment with wider regulatory plans.
- Support international engagement with other regulators, including at the International Medical Devices Regulators Forum (IMDRF).
Who are we looking for?
Our successful candidate will demonstrate the following:
- Minimum of a Bachelors degree or equivalent experience
- Working knowledge of the UK and/or EU Medical Devices legislation
- Experience of communicating with a range of stakeholders in the development and / or delivery of policy objectives
- Experience of policy development in a regulatory environment with ability to draft a range of policy and guidance documents for different audiences
Person Specification:
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
- Leadership (A,I)
- Communicating and Influencing (A,I)
- Working Together (A,I)
- Seeing the Big Picture (A,I)
Experience Criteria:
- Experience of policy development in a regulatory environment (A,I)
- 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!
The selection process: We use the Civil Service Success Profiles to assess our candidates. 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: Leadership. 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.
If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.
Closing date: 31st July 2026
Shortlisting date: from 3rd August 2026
Interview date: from 31st August 2026
If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk
Diagnostic Regulatory Specialist in London employer: Medicines and Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an exceptional employer, offering a dynamic work environment in the heart of Canary Wharf, London. With a strong commitment to employee growth, the agency provides opportunities for professional development and collaboration with leading experts in healthcare and research. The hybrid working model promotes a healthy work-life balance, while the agency's focus on innovation and public health ensures that employees contribute to meaningful projects that enhance the well-being of millions.
Contact Details:
Medicines and Healthcare Products Regulatory Agency Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Diagnostic Regulatory Specialist in London
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We think you need these skills to ace Diagnostic Regulatory Specialist in London
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Medicines and Healthcare Products Regulatory Agency.
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Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Medicines and Healthcare Products Regulatory Agency. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Medicines and Healthcare Products Regulatory Agency. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Medicines and Healthcare Products Regulatory Agency
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Medicines and Healthcare Products Regulatory Agency’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
