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- Tasks: Ensure compliance of medical devices with UK and international regulations while managing quality systems.
- Company: Join a dynamic team in a leading medical device company based in Liverpool.
- Benefits: Full-time role with opportunities for professional growth and development.
- Why this job: Make a real difference in healthcare by ensuring product safety and compliance.
- Qualifications: Bachelor's degree and 2-3 years' experience in QA/RA within medical devices.
- Other info: Fast-paced environment with a focus on innovation and regulatory excellence.
Location: Liverpool, UK
Employment Type: Full‑Time, Permanent
Department: Quality & Regulatory Affairs (QARA)
About the Role
We are seeking a proactive Quality & Regulatory Affairs Officer to join a growing team. In this dual-function role, you will support the ongoing compliance of their Quality Management System (QMS) and contribute to Regulatory Affairs (RA) activities ensuring our medical device products meet all UK and international regulatory standards. This is an exciting opportunity for someone with solid QA/RA experience in the medical device industry who is looking to develop their expertise in a fast‑paced, compliance‑driven environment.
Key Responsibilities
- Maintain and control QMS documentation in line with ISO 13485:2016.
- Conduct internal audits and support CAPA/NCR investigations and closure.
- Assist in supplier qualification, audits, and quality agreements.
- Prepare and maintain Technical Files and regulatory documentation.
- Support UKCA and CE marking activities.
- Liaise with MHRA, Notified Bodies and other global authorities.
- Manage Post‑Market Surveillance, including complaint handling and vigilance reporting.
- Monitor changes to relevant medical device regulations and standards.
About You
Essential:
- Bachelor's degree in a scientific, engineering, or life science discipline.
- 2-3 years' experience in Quality Assurance or Regulatory Affairs within medical devices.
- Strong knowledge of ISO 13485, UK MDR, and EU MDR (2017/745).
- Internal auditing experience.
- Excellent communication, documentation control, and technical writing skills.
Desirable:
- Experience with MDR transition audits and interacting with Notified Bodies.
- Understanding of risk management (ISO 14971) and biocompatibility (ISO 10993).
- Familiarity with eQMS platforms.
- Professional memberships (TOPRA, RAPS, CQI, ASQ).
QA/RA Officer in Liverpool employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA/RA Officer in Liverpool
✨Tip Number 1
Network like a pro! Reach out to folks in the QA/RA field on LinkedIn or at industry events. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and UK MDR regulations. We want to see you shine, so practice answering common interview questions related to quality management systems and regulatory affairs.
✨Tip Number 3
Showcase your experience with real-life examples during interviews. We love hearing about how you've tackled challenges in QA/RA before, so be ready to share those stories that highlight your skills and expertise.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate candidates who are eager to join our team.
We think you need these skills to ace QA/RA Officer in Liverpool
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA/RA Officer role. Highlight your experience in Quality Assurance and Regulatory Affairs, especially in the medical device industry. We want to see how your skills match what we're looking for!
Showcase Your Skills: In your cover letter, don’t just list your qualifications; showcase your skills! Talk about specific projects or experiences that demonstrate your knowledge of ISO 13485 and regulatory standards. This is your chance to shine!
Be Clear and Concise: When writing your application, keep it clear and concise. Use straightforward language and avoid jargon unless it's relevant. We appreciate a well-structured application that gets straight to the point!
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 shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at SRG
✨Know Your Standards
Make sure you brush up on ISO 13485:2016 and the UK MDR before your 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 compliance in the medical device industry.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve conducted internal audits or managed CAPA/NCR investigations. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to see how your experience aligns with their needs.
✨Stay Updated on Regulations
Demonstrate your proactive approach by discussing recent changes in medical device regulations. This shows that you’re not only knowledgeable but also committed to staying informed, which is crucial in a fast-paced compliance-driven environment.
✨Communicate Clearly
Since excellent communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Whether it’s discussing technical documentation or liaising with regulatory bodies, being able to convey complex information simply will set you apart.
