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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: Collaborative environment with opportunities to work across various departments.
The predicted salary is between 30000 - 50000 £ 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
- Maintain regulatory compliance and obligations to international regulations.
- Organise related technical documentation.
- 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.
Omega Resource Group is acting as an Employment Agency in relation to this vacancy.
Omega Resource Group is an employment agency specialising in opportunities at all levels within the Engineering, Aerospace, Automotive, Electronics, Defence, Scientific, Oil & Gas, Construction and Manufacturing sectors.
For details of other opportunities available within your chosen field please visit our website www.omegaresource.co.uk.
Regulatory Affairs Associate in Cheltenham employer: Omega
Contact Detail:
Omega Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate in Cheltenham
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Regulatory Affairs Associate role.
✨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. Show them you’re the organised detail-oriented person they need!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to make it personal.
✨Tip Number 4
Apply through our website for the best chance at landing that job! We’ve got loads of resources to help you along the way, so take advantage of everything we offer to boost your application.
We think you need these skills to ace Regulatory Affairs Associate in Cheltenham
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 in medical device regulations or quality roles. We’re keen on seeing how you’ve navigated compliance and documentation in past positions.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy and ensures your application goes directly to us. Don’t miss out on this opportunity!
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 walk through your contributions will demonstrate your hands-on experience.
✨Show Your Team Spirit
This role involves collaboration with various departments. Be prepared to share examples of how you’ve successfully partnered with teams like Engineering or Quality Assurance to meet regulatory deliverables. Highlighting your teamwork skills can set you apart.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to regulatory changes 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.
