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.
Job Description
Job Title: Regulatory Associate – Medical Devices
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 in Eton 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. Our collaborative work culture fosters professional growth and encourages autonomy, allowing you to make a meaningful impact on patient safety and product success. With flexible hybrid working options and a commitment to continuous improvement, we offer an exceptional environment for those looking to advance their careers in the medical device sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Eton
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like GxPeople Global looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Specialist in Eton
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at GxPeople Global. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at GxPeople Global
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with GxPeople Global’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
