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- Tasks: Manage product complaints and drive effective CAPA actions in a regulated environment.
- Company: Join a leading company focused on quality and regulatory excellence.
- Benefits: Competitive salary up to £50K, professional development, and a supportive work culture.
- Why this job: Make a real impact by ensuring product safety and compliance while driving continuous improvement.
- Qualifications: Experience in Quality Assurance or Regulatory Affairs with strong analytical and communication skills.
- Other info: Opportunity for career growth in a dynamic and innovative industry.
The predicted salary is between 50000 - 50000 £ per year.
Are you a proactive Quality & Regulatory Affairs Specialist ready to take ownership of product complaint handling, investigation, and CAPA within a regulated environment? This role is ideal for someone who thrives on getting to the root of issues, driving supplier accountability, and ensuring products remain safe, compliant, and audit‑ready.
Tasks in the role include:
- Manage the full lifecycle of product complaints, from intake to closure
- Lead structured investigations and root‑cause analysis
- Communicate directly with suppliers, challenge investigation quality, and issue SCARs where needed
- Drive effective CAPA actions, ensuring timely implementation and robust effectiveness checks
- Maintain high‑quality documentation aligned with ISO 13485, MDR, MDSAP, FDA 21 CFR 820 or similar
- Support audits, trend analysis, and continuous improvement across the QMS
- Trained internal auditor would be an advantage
- Assist in Regulatory registrations, e.g. EUDAMED, MedEnvoy, etc
Required experience:
- Experience in Quality Assurance or Regulatory Affairs within a regulated industry
- Strong understanding of complaint handling, nonconformities, and CAPA
- Confident communicator able to work assertively with suppliers and internal teams
- Analytical mindset with excellent documentation skills
- Knowledge of ISO 13485, MDR and MDSAP frameworks
- Basic understanding of Technical File compilation
If this sounds of interest, please apply below.
Locations
Quality and Regulatory Affairs Specialist - Up to £50K in Somerset, Taunton employer: Sharpe Search
Contact Detail:
Sharpe Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Regulatory Affairs Specialist - Up to £50K in Somerset, Taunton
✨Tip Number 1
Network like a pro! Reach out to your connections in the Quality and Regulatory Affairs field. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and CAPA processes. Be ready to discuss how you've handled product complaints in the past. We want to see your analytical mindset in action!
✨Tip Number 3
Showcase your communication skills! When you get the chance to speak with potential employers, make sure to highlight your experience in challenging suppliers and driving accountability. This is key in Quality and Regulatory roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and take the initiative to connect directly with us.
We think you need these skills to ace Quality and Regulatory Affairs Specialist - Up to £50K in Somerset, Taunton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Quality Assurance or Regulatory Affairs. We want to see how your skills align with the role, so don’t be shy about showcasing your complaint handling and CAPA expertise!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality and regulatory affairs. Share specific examples of how you've driven supplier accountability or managed product complaints effectively.
Show Off Your Documentation Skills: Since maintaining high-quality documentation is key for us, make sure to mention any experience you have with ISO 13485, MDR, or similar standards. Highlighting your analytical mindset will also help us see your fit for the role!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Sharpe Search
✨Know Your Regulations
Make sure you brush up on ISO 13485, MDR, and MDSAP frameworks 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 them in real-world scenarios.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific product complaints or CAPA actions. Think of examples from your past experience where you successfully managed similar situations, and be ready to explain your thought process and the outcomes.
✨Show Your Analytical Skills
Since this role requires a strong analytical mindset, prepare to discuss how you approach root-cause analysis. You might even want to bring a case study or example of a structured investigation you led, highlighting your documentation skills and the impact of your findings.
✨Communicate Effectively
As a Quality & Regulatory Affairs Specialist, you'll need to communicate assertively with suppliers and internal teams. Practice articulating your thoughts clearly and confidently, and be prepared to demonstrate how you’ve successfully navigated challenging conversations in the past.