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- Tasks: Manage product complaints and drive investigations in a regulated environment.
- Company: Join a leading company focused on quality and compliance.
- Benefits: Competitive salary up to £50K, professional development, and a supportive team.
- Why this job: Make a real impact by ensuring product safety and compliance.
- Qualifications: Experience in Quality Assurance or Regulatory Affairs is essential.
- Other info: Opportunity for 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.
Quality and Regulatory Affairs Specialist - Up to £50K in 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 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 you to showcase your analytical mindset and problem-solving skills!
✨Tip Number 3
Practice your communication skills! Since this role involves working closely with suppliers and internal teams, being able to articulate your thoughts clearly is key. Try mock interviews with friends or use online platforms to refine your pitch.
✨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 Taunton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Quality Assurance and Regulatory Affairs. We want to see how your skills align with the job description, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. We love seeing enthusiasm and a clear understanding of the responsibilities, so make it personal and engaging.
Showcase Your Analytical Skills: Since this role requires an analytical mindset, include examples of how you've tackled complex problems in the past. We want to know how you approach investigations and root-cause analysis, so share those success stories!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re keen on joining our team at StudySmarter!
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 situations. Think of examples from your past experience where you successfully managed similar issues, 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 want to bring along a case study or example that highlights your problem-solving skills and how you drive continuous improvement.
✨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 challenge investigation quality if needed during the interview.