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- Tasks: Ensure regulatory compliance and manage technical documentation for medical devices.
- Company: Global leading manufacturing business based in Gloucester.
- Benefits: Permanent position with hybrid working options and career development opportunities.
- Why this job: Join a dynamic team and make a difference in the medical device industry.
- Qualifications: Experience in regulatory affairs and understanding of medical device standards required.
- Other info: Collaborate with various departments to ensure timely regulatory deliverables.
The predicted salary is between 28800 - 48000 £ per year.
Location: Gloucester
Job Type: Permanent / Onsite (Hybrid)
Our client, a global leading manufacturing business based in Gloucester, is on the hunt for a detailed and organised Regulatory Affairs Associate!
Role and Responsibilities – Regulatory Affairs Associate
In this role, your key responsibility is to maintain regulatory compliance, obligations to international regulations, and organisation of related technical documentation. Other responsibilities include:
- Ensure documentation aligns with ISO 13485, ISO 14971 and where applicable IEC 62366-1
- Support preparation, review, and maintenance of Technical Documentation, including device description, GSPR, risk management, clinical evaluation, PMS, PMCF, and labelling.
- Partner with R&I, Engineering, Quality, Manufacturing, Sales and Supply Chain to ensure regulatory deliverables are embedded and on time
- Support international registrations (e.g., FDA listing support, Canada, Australia) as business needs evolve.
Experience or Qualifications – Regulatory Affairs Associate
- Proven experience in a medical device regulatory / quality role
- Sound understanding of regulatory processes within med devices standards (ISO 13485, MDR, FDA 21 CFR Part 280)
- Internal QMS auditing experience
- Ability to prioritise and deliver to deadlines in a regulated environment.
Candidates who currently are a Regulatory Affairs Associate, Regulatory Affairs Engineer, Regulatory Affairs Specialist or Quality & Regulatory Associate may be suitable for this position.
For more information regarding this Regulatory Affairs Associate role please contact Ben Herd on 01453 829523 or ben.herd@omegaresource.co.uk
Regulatory Affairs Associate in Gloucester employer: Omega
Contact Detail:
Omega Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate in Gloucester
✨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 ISO standards and regulatory processes. We recommend practising common interview questions related to compliance and documentation to show you’re the right fit for the role.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications after a week or so. A quick email can show your enthusiasm and keep you on their radar. We believe persistence pays off!
✨Tip Number 4
Check out our website for more opportunities and resources tailored to your career in regulatory affairs. We’ve got your back in finding the perfect role that matches your skills and aspirations!
We think you need these skills to ace Regulatory Affairs Associate in Gloucester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Associate role. Highlight your experience with ISO standards and regulatory processes, as these are key for us. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can benefit our team. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience: When filling out your application, be sure to showcase any relevant experience you have in medical device regulations or quality roles. We’re keen on seeing how you’ve navigated similar challenges 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 makes the process smoother for everyone involved!
How to prepare for a job interview at Omega
✨Know Your Regulations
Make sure you brush up on ISO 13485, ISO 14971, and FDA regulations before the interview. Being able to discuss these standards confidently will show that you’re not just familiar with them but can apply them in real-world scenarios.
✨Prepare Your Documentation Examples
Have specific examples of technical documentation you've worked on ready to discuss. Whether it’s device descriptions or risk management plans, being able to articulate your experience will demonstrate your hands-on knowledge in regulatory affairs.
✨Show Your Team Spirit
This role involves collaboration with various departments like Engineering and Quality. Be prepared to share examples of how you’ve successfully partnered with other teams in the past to meet regulatory deliverables. It’s all about teamwork!
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to regulatory compliance or how they handle international registrations. This shows your genuine interest in the role and helps you gauge if it’s the right fit for you.
