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- Tasks: Join our team as a Regulatory Associate, ensuring compliance in the medical device sector.
- Company: We're a dynamic company focused on innovation and patient safety in medical devices.
- Benefits: Enjoy hybrid work options, a collaborative environment, and opportunities for professional growth.
- Why this job: Make a real impact on global patient access while working with a passionate team.
- Qualifications: Degree in a scientific or engineering field; experience with Medical Devices and regulatory frameworks 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
Candidate Profile
- 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 but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the Regulatory Affairs community, especially those who have experience with medical devices. Attend industry conferences or webinars to make connections and gain insights that could give you an edge during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to regulatory compliance in previous roles. Highlighting your hands-on experience with Technical Files and audits will show that you can hit the ground running.
✨Tip Number 4
Research StudySmarter's values and mission to align your responses during interviews. Showing that you resonate with our commitment to quality and innovation can set you apart as a candidate who truly fits our team culture.
We think you need these skills to ace Regulatory Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with Medical Devices, particularly your knowledge of the Medical Device Directive and EU MDR. Use specific examples that demonstrate your understanding of regulatory compliance and your ability to manage Technical Files.
Craft a Compelling Cover Note: In your cover note, clearly outline why you are a great fit for the Regulatory Associate role. Mention your relevant qualifications, experience with CE Marking, and any specific achievements in regulatory affairs that showcase your skills.
Highlight Relevant Skills: Emphasise your analytical and problem-solving skills in your application. Provide examples of how you've successfully navigated regulatory challenges or contributed to compliance processes in previous roles.
Show Enthusiasm for the Role: Express your passion for regulatory affairs and patient safety in your application. Mention why you are excited about the opportunity to work in a collaborative team and how you can contribute to the company's mission of enhancing global patient access to medical devices.
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 regulations or manage compliance issues, and be ready to explain your thought process.
✨Emphasise Team Collaboration
Since the role involves working closely with cross-functional teams, be sure to discuss your experience in collaborative environments. Share examples of how you've successfully worked with others to achieve regulatory goals and ensure product compliance.
