At a Glance
- Tasks: Ensure regulatory compliance for life-changing medical devices across global markets.
- Company: Dynamic medical device manufacturer with a collaborative and quality-focused culture.
- Benefits: Competitive salary, flexible working, and opportunities for national and international travel.
- Other info: Join a forward-thinking team with excellent career growth potential.
- Why this job: Make a real impact in healthcare while developing your skills in a supportive environment.
- Qualifications: 2+ years in medical device regulatory or quality with strong attention to detail.
The predicted salary is between 42000 - 44000 £ per year.
Office-based (with some flexibility) Occasional national & international travel Salary: £42,000 -£44,000 Location: Gloucester
We are looking for a detail-driven and motivated Regulatory Affairs Associate to join a growing and dynamic team within the medical devices sector. This is a fantastic opportunity to play a key role in ensuring regulatory compliance across international markets, supporting the development of life-changing products while working in a highly collaborative, quality-focused environment.
What You'll Do
- Support MDR technical documentation (Annex II & III)
- Contribute to UK & international registrations (MHRA, EU, FDA)
- Maintain ISO 13485 compliant documentation
- Assist with PMS, vigilance, and audits
- Collaborate across Engineering, Quality & Manufacturing
- Review labelling and compliance for global markets
What You'll Bring
- 2+ years in medical device regulatory or quality
- Strong knowledge of MDR, MDD & ISO 13485
- Excellent attention to detail & technical writing
- A proactive, organised and team-focused mindset
If you're an experienced professional looking to make a significant impact within a forward-thinking medical device manufacturer, apply today through Hawk 3 Talent Solutions.
Closing date is 27.06.2026. Please note this could change subject to suitable applications.
Regulatory Affairs Associate employer: Hawk 3 Talent Solutions
Join a forward-thinking medical device manufacturer in Gloucester, where you will thrive in a collaborative and quality-focused environment. With competitive salaries and opportunities for national and international travel, we prioritise employee growth and development, ensuring that you play a vital role in bringing life-changing products to market while enjoying a supportive workplace culture.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Associate
✨Tip Number 1
Network like a pro! Reach out to people in the medical device sector, especially those working in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDR, MDD, and ISO 13485. We want you to showcase your expertise and attention to detail, so practice answering questions related to these regulations.
✨Tip Number 3
Don’t just apply; follow up! After sending your application through our website, drop a quick email to express your enthusiasm. It shows initiative and keeps you on their radar.
✨Tip Number 4
Stay organised! Keep track of the roles you’ve applied for and any conversations you’ve had. This will help you tailor your follow-ups and prepare for potential interviews with confidence.
We think you need these skills to ace Regulatory Affairs Associate
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Associate role. Highlight your experience with MDR, MDD, and ISO 13485, as well as any relevant technical writing skills. We want to see how your background aligns with what we're looking for!
Show Off Your Attention to Detail:Since this role requires excellent attention to detail, make sure your application is free from typos and errors. We appreciate a polished application that reflects your meticulous nature—it's a key trait for success in our team!
Be Proactive in Your Cover Letter:Use your cover letter to showcase your proactive mindset and team-focused attitude. Share specific examples of how you've contributed to regulatory compliance or collaborated across departments in previous roles. We love seeing candidates who take initiative!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates. Plus, it’s super easy—just a few clicks and you’re done!
How to prepare for a job interview at Hawk 3 Talent Solutions
✨Know Your Regulations
Make sure you brush up on your knowledge of MDR, MDD, and ISO 13485 before the interview. Being able to discuss these regulations confidently will show that you're not just familiar with them, but that you can apply this knowledge in a practical setting.
✨Showcase Your Attention to Detail
Prepare examples from your past experience where your attention to detail made a difference. Whether it was during documentation or compliance checks, having specific instances ready will demonstrate your capability to maintain high standards in regulatory affairs.
✨Collaborative Mindset
Since the role involves working closely with Engineering, Quality, and Manufacturing teams, be ready to discuss how you've successfully collaborated in the past. Highlighting your team-focused mindset will resonate well with the interviewers.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to regulatory compliance and their future projects. This not only shows your genuine interest in the role but also gives you a chance to assess if the company aligns with your career goals.