At a Glance
- Tasks: Lead regulatory projects and support market surveillance for medical devices.
- Company: Join the Medicines and Healthcare products Regulatory Agency, enhancing health for millions.
- Benefits: Permanent home-based role with occasional travel, competitive salary, and career growth.
- Other info: Dynamic team environment with opportunities for professional development.
- Why this job: Make a real impact in healthcare regulation and innovation.
- Qualifications: Experience in medical device regulations and project management skills required.
The predicted salary is between 40000 - 50000 £ per year.
We are currently looking for a Regulatory Affairs Lead – Project to join our Standards & Compliance Function within the Health Quality and Access group. This is a full-time opportunity, on a permanent basis. The role is home-based but will require occasional travel to 10 South Colonnade, Canary Wharf London, E14 4PU and South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas.
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 Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. The Standards & Compliance function enables innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Inspectorate, the Inspection Action Group and Devices Audit and Compliance.
What’s the role? This role is primarily responsible for providing regulatory support to the Agency’s proactive Market Surveillance and Approved Body Team. The post holder will be responsible for supporting senior management with the planning and coordination of MHRA’s proactive Market Surveillance plan which includes direct audits of medical device manufacturers (including economic operators) and review of technical documentation together with the development and delivery of the Approved Bodies plan.
Key responsibilities:
- Lead and coordinate key projects supporting delivery of the Approved Body oversight plan and proactive Market Surveillance strategy, ensuring clear milestones, tracking, and timely delivery.
- Provide insight and feedback to senior management on progress, risks, and operational challenges to inform decision making.
- Drive cross-team collaboration to ensure alignment and effective delivery of project activities.
- Provide input into internal policy development to strengthen regulatory and operational frameworks.
Who are we looking for?
Our successful candidate will demonstrate the following:
- Communicating and Influencing
- Making effective decisions
- Working Together
- Analytical and Regulatory Expertise
- Project Management
Person Specification:
Method of assessment: A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
- Communicating & Influencing (A,I,P)
- Working Together (I, P)
- Making Effective Decisions (I,P)
Experience Criteria:
- Knowledge and understanding of the Medical Device Regulations, medical device vigilance, complaint handling, risk management, and regulatory reporting. (A,P)
- Proven ability to understand and assess the impact of policy and regulatory changes. Leads on new recommendation proposals and has ability to implement necessary changes. (A,I)
- Demonstrate experience coordinating or delivering projects, including planning, tracking progress, managing risks, and delivering to deadlines and demonstrate how a new process or programme of work has been successfully planned and implemented. (A,I,P)
Technical Criteria:
- University degree or equivalent knowledge / experience gained in the industrial arena and ability to demonstrate capability. (A)
- Experience working in medical device regulatory affairs or for medical device manufacturers. (A,I)
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
Closing date: 13th June 2026
Shortlisting date: from 15th June 2026
Interview date: week commencing 13th July 2026
Regulatory Affairs Lead - Project employer: Medicines and Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration within the healthcare sector. With a strong commitment to employee development, the agency provides numerous growth opportunities and a supportive culture that values teamwork and effective communication. Located in the vibrant Canary Wharf area, employees benefit from a flexible home-based role with occasional travel, ensuring a balanced work-life experience while contributing to the health and safety of millions.
Contact Details:
Medicines and Healthcare Products Regulatory Agency Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Lead - Project
✨Tip Number 1
Network like a pro! Reach out to folks in the regulatory affairs space, especially those who work with medical devices. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for your interview by diving deep into the Medical Device Regulations. Brush up on your knowledge and be ready to discuss how you’ve tackled similar challenges in past roles. We want to see your analytical skills in action!
✨Tip Number 3
Show off your project management chops! Be ready to share specific examples of projects you've led, focusing on how you managed risks and ensured timely delivery. This is key for the role, so make it shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Regulatory Affairs Lead - Project
Some tips for your application 🫡
Read the Job Description Carefully:Before you start your application, take a good look at the job description. It’s packed with info about what we’re looking for, so make sure you understand the key responsibilities and requirements. This will help you tailor your application to show us why you're the perfect fit!
Be Specific in Your Examples:When answering the application questions, don’t just say you have experience—show it! Use specific examples from your past work that demonstrate your skills and how they relate to the role. We want to see how you’ve tackled challenges and achieved results.
Keep It Clear and Concise:We appreciate clarity! Make sure your answers are straightforward and to the point. Avoid jargon unless it’s relevant to the role. Remember, we’re looking for your ability to communicate effectively, so let your writing reflect that.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way to ensure your application gets to us without any hiccups. Plus, you’ll find all the necessary details and updates there, so it’s a win-win!
How to prepare for a job interview at Medicines and Healthcare Products Regulatory Agency
✨Know Your Regulations
Make sure you brush up on the Medical Device Regulations and related compliance standards. Being able to discuss these confidently will show that you understand the core of the role and can contribute effectively from day one.
✨Prepare for Behavioural Questions
Expect questions around communicating, influencing, and decision-making. Use the STAR method (Situation, Task, Action, Result) to structure your answers, showcasing your past experiences in regulatory affairs and project management.
✨Showcase Your Project Management Skills
Be ready to discuss specific projects you've led or contributed to. Highlight how you planned, tracked progress, and managed risks. This will demonstrate your ability to coordinate effectively within the team and deliver results.
✨Engage with the Interviewers
Don’t just answer questions; engage in a dialogue. Ask insightful questions about the team's current projects or challenges they face. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
