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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 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
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.
- 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.
Regulatory Affairs Associate in Gloucester employer: Omega Resource Group
Contact Detail:
Omega Resource Group 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 people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory processes. Show them you understand their needs and how your experience aligns with their goals. Confidence is key!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can set you apart from other candidates. It shows your enthusiasm and keeps you fresh in their minds.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities that might just be the perfect fit for you. Keep an eye out and get your applications in!
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 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 Resource Group
✨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 that you understand their importance in maintaining regulatory compliance.
✨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 talk through your experience will demonstrate your hands-on knowledge and attention to detail.
✨Collaborative Mindset
Since this role involves partnering with various departments, be prepared to discuss how you’ve successfully collaborated with teams like Engineering or Quality in the past. Share examples that highlight your ability to work cross-functionally and meet deadlines.
✨Stay Current with Industry Trends
Show your enthusiasm for the field by discussing recent changes in regulatory affairs or new technologies in medical devices. This will not only impress your interviewers but also demonstrate your commitment to staying informed and proactive in your career.
