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- Tasks: Manage product complaints and lead investigations to ensure compliance and safety.
- Company: Join a dynamic team in a regulated industry focused on quality and innovation.
- Benefits: Competitive salary up to £45K, professional development, and a supportive work environment.
- Why this job: Make a real impact by ensuring products are safe and compliant 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 fast-paced, quality-driven environment.
The predicted salary is between 40000 - 45000 £ 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
Quality and Regulatory Affairs Specialist - Up to £45K 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 £45K in Taunton
✨Tip Number 1
Network like a pro! Reach out to your connections in the Quality and Regulatory Affairs field. We all know that sometimes it’s not just what you know, but who you know. Attend industry events or webinars to meet potential employers and make a lasting impression.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and CAPA processes. We want you to be able to discuss your experience confidently and show how you can drive supplier accountability. Practice common interview questions and have examples ready to demonstrate your analytical mindset.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation. It shows you’re proactive and genuinely interested in the role. Plus, it keeps you fresh in their minds!
✨Tip Number 4
Apply through our website for the best chance at landing that Quality and Regulatory Affairs Specialist role. We’ve got all the latest openings, and applying directly can sometimes give you an edge over other candidates. Let’s get you that job!
We think you need these skills to ace Quality and Regulatory Affairs Specialist - Up to £45K in Taunton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the role of Quality and Regulatory Affairs Specialist. Highlight your experience in complaint handling, CAPA, and any relevant regulatory frameworks like ISO 13485 or MDR. We want to see how your skills align with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you’re passionate about quality assurance and regulatory affairs. Share specific examples of how you've tackled challenges in previous roles, especially those that relate to product complaints and investigations.
Show Off Your Documentation Skills: Since documentation is key in this role, make sure to showcase your attention to detail. Whether it’s through your CV or cover letter, mention any experience you have with maintaining high-quality documentation and how you ensure compliance with standards like FDA 21 CFR 820.
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. Plus, it shows us you’re keen to join the StudySmarter 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 can also apply them in real-world scenarios.
✨Prepare for Scenario Questions
Expect questions about how you've handled product complaints or CAPA in the past. Prepare specific examples that highlight your analytical mindset and problem-solving skills. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Show Your Communication Skills
Since this role involves direct communication with suppliers, practice articulating your thoughts clearly and assertively. Think of examples where you’ve successfully challenged investigation quality or driven accountability, as this will demonstrate your confidence and ability to collaborate effectively.
✨Highlight Your Documentation Skills
Documentation is key in Quality and Regulatory Affairs. Be ready to discuss your experience with maintaining high-quality documentation and how you ensure compliance. Bring along samples of your work if possible, as this can really set you apart from other candidates.