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- Tasks: Join our team to ensure medical devices meet global compliance standards.
- Company: We're a dynamic company focused on innovation in the medical device sector.
- Benefits: Enjoy hybrid work options and a collaborative team environment.
- Why this job: Make a real impact on patient safety while advancing your career in regulatory affairs.
- Qualifications: Degree in a scientific or engineering discipline with experience in medical devices required.
- Other info: Opportunity to shape compliance processes and participate in audits.
The predicted salary is between 36000 - 60000 £ per year.
Location: West London/ Berkshire (Hybrid or On-site, depending on candidate location)
Employment Type: Full-Time
Are you looking to advance your career in Regulatory Affairs within a fast-paced and impactful medical device environment? We’re hiring a Regulatory Associate to join a highly collaborative RA/QA team and play a central role in global product compliance and regulatory strategy execution.
This is an exciting opportunity for someone with strong knowledge of the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485, who thrives on autonomy, ownership, and making a real contribution to patient safety and product success.
Key Responsibilities- Prepare and maintain global regulatory submissions and renewal
- Support external distributors, authorised reps, and internal teams on regulatory matters
- Compile and maintain MDR-compliant Technical Files and related documentation
- Lead the transition of existing MDD Technical Files to MDR format
- Manage post-market surveillance activities and clinical evaluation maintenance
- Conduct and support complaint trend analysis and ensure accurate reporting
- Monitor changes in global regulatory frameworks and advise management accordingly
- Participate in external audits (e.g. Notified Body) and host internal audits
- Review and approve product, labelling, and process changes for regulatory impact
- Ensure full regulatory compliance in EU, US, and other territories as required
- Liaise with Notified Bodies and coordinate Technical File audits
- Degree (2:1 or above) in a scientific or engineering discipline
- Proven experience working with Medical Devices under 93/42/EEC and MDR 2017/745
- Strong understanding of CE Marking, ISO 13485, ISO 14971, and GMP
- Familiar with medical device labelling (ISO 15223) and Essential Requirements Checklists
- Experience liaising with Notified Bodies and supporting audits
- Confident in authoring and maintaining Declarations of Conformity and Technical Files
- Highly organised, hands-on, and commercially astute
- Excellent communication, analytical, and problem-solving skills
- Ability to work independently and collaboratively in cross-functional teams
Why Apply? You’ll be joining a passionate team that values quality, innovation, and continuous improvement. This role offers a unique opportunity to shape compliance processes and directly impact global patient access to life-enhancing medical devices.
To apply, please submit your CV and a short cover note outlining your suitability. For a confidential discussion about the role, feel free to get in touch directly.
Regulatory Specialist employer: GxPeople Global
Contact Detail:
GxPeople Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist
✨Tip Number 1
Familiarise yourself with the latest updates on the Medical Device Directive and EU MDR regulations. Being well-versed in these areas will not only boost your confidence during interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who work with medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory compliance.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your knowledge of ISO standards and your ability to manage regulatory submissions. Real-life scenarios can help illustrate your problem-solving skills and your understanding of compliance processes.
✨Tip Number 4
Research StudySmarter's values and mission to align your responses during the interview. Showing that you resonate with our commitment to quality and innovation can set you apart as a candidate who is genuinely interested in contributing to our team.
We think you need these skills to ace Regulatory Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Regulatory Specialist position. Familiarise yourself with the Medical Device Directive, EU MDR, and ISO standards mentioned in the job description.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the job description. Emphasise your knowledge of regulatory compliance, technical file management, and any experience with Notified Bodies.
Craft a Compelling Cover Note: Write a concise cover note that outlines your suitability for the role. Mention specific experiences that demonstrate your understanding of regulatory affairs and your ability to contribute to patient safety and product success.
Proofread Your Application: Before submitting, carefully proofread your CV and cover note for any errors or typos. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at GxPeople Global
✨Know Your Regulations
Make sure you have a solid understanding of the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485. Be prepared to discuss how these regulations impact your previous work and how you can apply this knowledge in the new role.
✨Showcase Your Experience
Highlight your experience with regulatory submissions, Technical Files, and liaising with Notified Bodies. Use specific examples from your past roles to demonstrate your expertise and how it aligns with the responsibilities of the position.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle regulatory challenges. Think of scenarios where you had to navigate complex regulatory issues and be ready to explain your thought process and outcomes.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory strategy and how they approach compliance. This shows your genuine interest in the role and helps you understand if the company’s values align with yours.
