At a Glance
- Tasks: Prepare regulatory submissions and ensure compliance for medical devices.
- Company: Dynamic medical device company focused on innovation and patient safety.
- Benefits: Full-time role with hybrid work options and a collaborative team environment.
- Other info: Join a passionate team dedicated to quality and continuous improvement.
- Why this job: Make a real impact on global patient access to life-enhancing medical devices.
- Qualifications: Degree in science or engineering and experience with medical device regulations.
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 Affairs Specialist employer: GxPeople Global
Join a dynamic and innovative team in West London/Berkshire, where your expertise as a Regulatory Affairs Specialist will be valued and nurtured. We offer a collaborative work culture that prioritises quality and continuous improvement, alongside opportunities for professional growth and development in the fast-evolving medical device sector. Enjoy the flexibility of hybrid working arrangements while making a meaningful impact on global patient safety and product success.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of the Medical Device Directive and EU MDR. We recommend practising common interview questions and scenarios related to regulatory compliance to show you’re ready to hit the ground running.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your skills, especially in the medical device sector.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can help you stand out from the crowd.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs role. Highlight your experience with Medical Devices and relevant regulations like MDR and ISO standards. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Note:Your cover note is your chance to shine! Keep it concise but impactful. Share why you’re excited about this role and how your skills can contribute to our team. Remember, we love passion and enthusiasm!
Showcase Your Experience:When detailing your experience, focus on specific achievements related to regulatory submissions and compliance. We’re keen to see examples of how you’ve navigated complex regulatory frameworks in the past.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at GxPeople Global
✨Know Your Regulations
Make sure you brush up on the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485. Being able to discuss these regulations confidently will show that you’re not just familiar with them, but that you understand their implications in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past work where you’ve successfully managed regulatory submissions or liaised with Notified Bodies. This will help demonstrate your hands-on experience and how you can contribute to the team’s success.
✨Ask Insightful Questions
Come prepared with questions about the company’s current compliance processes or challenges they face in regulatory affairs. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
✨Highlight Your Teamwork Skills
Since this role involves collaboration with various teams, be ready to discuss how you’ve worked effectively in cross-functional teams before. Share examples that highlight your communication and problem-solving skills, as these are crucial in a regulatory environment.
