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- Tasks: Ensure compliance with medical device regulations and manage quality systems.
- Company: Reputable provider of medical supplies with 50 years of experience.
- Benefits: Salary between £35,000 to £39,000, 23 days holiday increasing with service.
- Why this job: Make a real difference in healthcare by ensuring product safety and compliance.
- Qualifications: Experience in quality management and regulatory affairs in medical devices.
- Other info: Dynamic role with opportunities for professional growth in a supportive environment.
The predicted salary is between 30000 - 39000 £ per year.
We are recruiting on behalf of a client for a Quality & Regulatory Officer, Medical Devices.
Our client has 50 years of experience supporting businesses and the NHS; they are one of the biggest and most reputable providers of Medical Supplies in the UK.
- Sector: Medical Devices
- Location: Liverpool
- Salary: £35,000 to £39,000
- Holidays: 23 days increasing to 25 days with service
Role Summary: The Quality & Regulatory Affairs Officer is a crucial dual role responsible for ensuring the company's compliance with all applicable UK device regulations, primarily the UK Medical Devices Regulations (UK MDR) and the EU Medical Device Regulation (MDR, 2017/745).
The QARA Officer will manage day-to-day Quality Management System (QMS) activities and support regulatory compliance and submissions, ensuring our range of products – both sterile and non-sterile – are safe and compliant for market access.
Key Responsibilities:
- Quality Management System (QMS)
- Documentation Control: Maintain, update, and control all QMS documentation in accordance with ISO 13485:2016 requirements.
- Internal Auditing: Plan and execute internal audits to schedule, identifying non-conformities and tracking Corrective and Preventive Actions (CAPAs).
- CAPA & NCR Management: Lead the Non-Conformance Report (NCR) and CAPA processes.
- Supplier Management: Assist in qualifying and auditing suppliers, maintaining the Approved Supplier List, and ensuring supplier quality agreements are in place.
- Training: Develop and deliver QMS and regulatory training programs for personnel across all departments.
Apply now for further information and job description.
Quality & Regulatory Officer in Liverpool employer: McAllister Recruitment & Consultancy
Contact Detail:
McAllister Recruitment & Consultancy Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality & Regulatory Officer in Liverpool
✨Tip Number 1
Network like a pro! Reach out to people in the medical devices sector 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 Quality & Regulatory Officer role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK MDR and ISO 13485:2016. We want you to be able to discuss how you would manage QMS activities and handle CAPAs confidently. Show them you’re the expert they need!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We recommend mentioning something specific from your conversation to make it personal.
✨Tip Number 4
Apply through our website for the best chance! We’ve got all the latest job openings, and applying directly shows your enthusiasm. Let’s get you that Quality & Regulatory Officer position!
We think you need these skills to ace Quality & Regulatory Officer in Liverpool
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality & Regulatory Officer role. Highlight your experience with QMS, regulatory compliance, and any relevant certifications. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical devices and how your background makes you a perfect fit for our team. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience: When filling out your application, be sure to showcase any specific experience you have with ISO 13485:2016 or internal auditing. We’re keen on seeing how you’ve handled similar responsibilities in the past.
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’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at McAllister Recruitment & Consultancy
✨Know Your Regulations
Make sure you brush up on the UK Medical Devices Regulations and the EU MDR. Being able to discuss these regulations confidently will show that you're serious about the role and understand the compliance landscape.
✨Showcase Your QMS Experience
Prepare specific examples of your experience with Quality Management Systems, especially ISO 13485:2016. Discuss how you've maintained documentation control or executed internal audits in previous roles to demonstrate your hands-on knowledge.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to CAPA and NCR management. Think through how you would handle non-conformities or supplier issues, as this will highlight your problem-solving skills and regulatory acumen.
✨Highlight Your Training Skills
Since training is a key part of the role, be prepared to talk about any experience you have in developing or delivering training programs. Share how you’ve engaged others in understanding quality and regulatory processes, as this shows your ability to communicate effectively across departments.
