Devices Regulatory Specialist

Devices Regulatory Specialist

London Full-Time 30000 - 42000 £ / year (est.) No home office possible
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Medicines and Healthcare Products Regulatory Agency

At a Glance

  • Tasks: Support the development of regulatory frameworks for innovative medical devices and provide expert advice.
  • Company: Join the Medicines and Healthcare products Regulatory Agency, enhancing health through effective regulation.
  • Benefits: Enjoy flexible working options and a collaborative hybrid work environment.
  • Why this job: Be part of a dynamic team driving innovation in healthcare and making a real impact.
  • Qualifications: Bachelor’s degree required; knowledge of UK/EU medical device legislation preferred.
  • Other info: This role is only open to current Civil Service employees.

The predicted salary is between 30000 - 42000 £ per year.

Join to apply for the Devices Regulatory Specialist role at Medicines and Healthcare products Regulatory Agency

Join to apply for the Devices Regulatory Specialist role at Medicines and Healthcare products Regulatory Agency

Job Description
We are currently looking for a

Innovation 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

Job Description
We are currently looking for a Devices Regulatory Specialist to join our Innovative Devices Function within the Innovation 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.
What’s 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?
Our Successful Candidate Will

  • Be educated to at least Bachelor’s 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!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact
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 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 allow sufficient time. 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 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 .
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: civilservicecommission.independent.gov.uk

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.

Seniority level

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Devices Regulatory Specialist 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 public health and innovation, employees benefit from flexible working arrangements, opportunities for professional growth, and the chance to contribute to meaningful regulatory advancements that impact millions. The collaborative culture fosters engagement with diverse stakeholders, ensuring that every team member plays a vital role in shaping the future of medical devices and healthcare compliance.
Medicines and Healthcare Products Regulatory Agency

Contact Detail:

Medicines and Healthcare Products Regulatory Agency Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Devices Regulatory Specialist

✨Tip Number 1

Familiarise yourself with the UK and EU medical devices legislation. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to the role.

✨Tip Number 2

Network with professionals already working in regulatory roles within the Civil Service. Engaging with them can provide insights into the application process and what the agency values in candidates.

✨Tip Number 3

Prepare for competency-based questions by reflecting on your past experiences. Think about specific examples where you've developed policy or communicated with stakeholders, as these are key aspects of the role.

✨Tip Number 4

Stay updated on current trends and innovations in medical devices. Being knowledgeable about recent developments will show your enthusiasm for the field and your readiness to contribute to the agency's goals.

We think you need these skills to ace Devices Regulatory Specialist

Knowledge of UK and EU medical devices legislation
Policy development and legislative experience
Stakeholder engagement and communication skills
Strong written communication skills
Ability to draft policy and guidance documents
Analytical skills for regulatory analysis
Project management skills
Collaboration and teamwork abilities
Understanding of regulatory compliance frameworks
Experience in international regulatory engagement
Attention to detail
Adaptability to changing regulations
Problem-solving skills

Some tips for your application 🫡

Understand the Role: Before applying, make sure to thoroughly read the job description for the Devices Regulatory Specialist role. Understand the key responsibilities and required qualifications to tailor your application accordingly.

Highlight Relevant Experience: In your application, emphasise any experience you have with UK and EU medical devices legislation, as well as your ability to communicate effectively with various stakeholders. Use specific examples to demonstrate your skills.

Craft a Strong Personal Statement: Write a compelling personal statement that showcases your passion for regulatory compliance and innovation in medical devices. Make sure to align your motivations with the mission of the Medicines and Healthcare products Regulatory Agency.

Review and Edit: Before submitting your application, review it for clarity and conciseness. Ensure there are no grammatical errors and that all information is accurate. A well-polished application reflects your attention to detail.

How to prepare for a job interview at Medicines and Healthcare Products Regulatory Agency

✨Understand the Regulatory Landscape

Make sure you have a solid grasp of UK and EU medical devices legislation. Familiarise yourself with the key regulations, such as the UK Medical Devices Regulations 2002, EU MDR, and EU IVDR, as these will likely be central to your interview discussions.

✨Prepare for Competency-Based Questions

The interview will include competency-based questions, so review the competencies listed in the job description. Prepare specific examples from your past experiences that demonstrate your skills in developing policy, stakeholder communication, and regulatory compliance.

✨Showcase Your Communication Skills

Strong written and verbal communication skills are essential for this role. Be ready to discuss how you've effectively communicated complex regulatory information to various stakeholders, including manufacturers and healthcare professionals.

✨Engage with Current Trends

Stay updated on current trends and innovations in the medical devices sector, especially regarding software and AI. Being able to discuss recent developments or challenges in the industry will show your enthusiasm and knowledge during the interview.

Devices Regulatory Specialist
Medicines and Healthcare Products Regulatory Agency
Location: London
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