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- Tasks: Ensure quality compliance and drive continuous improvement in medical device manufacturing.
- Company: Join a leading company in laboratory sciences with a commitment to innovation.
- Benefits: Full-time role with opportunities for professional growth and development.
- Why this job: Make a real impact on healthcare by ensuring the quality of essential medical devices.
- Qualifications: Bachelor’s degree and 4 years’ experience in Quality Assurance or Regulatory Affairs.
- Other info: Collaborative environment with a focus on quality culture and career advancement.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Quality Assurance and Regulatory Affairs Specialist
Medical Wire & Equipment Co. (Bath) Ltd (MWE) has been at the forefront of laboratory sciences and pre‑analytical medical device manufacturing since 1952. Based in Corsham, we design and produce innovative specimen collection and transport systems used worldwide for the recovery of viruses, bacteria, and other microorganisms. Our success is built on scientific expertise, innovation, and a commitment to quality and compliance across multiple industries.
About Us
Medical Wire & Equipment Co. (Bath) Ltd (MWE) has been at the forefront of laboratory sciences and pre‑analytical medical device manufacturing since 1952. Based in Corsham, we design and produce innovative specimen collection and transport systems used worldwide for the recovery of viruses, bacteria, and other microorganisms. Our success is built on scientific expertise, innovation, and a commitment to quality and compliance across multiple industries.
The Role
We are seeking a Quality Assurance and Regulatory Affairs Specialist to support our Quality and Regulatory team in maintaining compliance with relevant medical device and IVD standards and regulations.
In this role, you will assist with activities to ensure continued certification and compliance, monitor and advise on the performance of the Quality Management System (QMS), and produce reports on performance against key indicators. You will play a key part in driving continuous improvement initiatives and promoting a strong quality culture throughout the organisation.
Key Responsibilities
- Support the implementation, maintenance, and improvement of the Quality Management System in accordance with applicable standards and regulations.
- Monitor and report on quality performance, including tracking and trending key performance indicators (KPIs).
- Contribute to regulatory submissions, technical documentation, and product registrations.
- Provide guidance on compliance with EU MDR and IVDR requirements, as well as other international regulations.
- Support internal and external audits and ensure timely resolution of findings.
- Drive problem‑solving and continuous improvement initiatives across departments.
- Support Quality Improvement and Master Plans for the site.
Qualifications and Experience
- Bachelor’s degree in a relevant discipline (e.g., Biomedical Engineering, Life Sciences, Regulatory Affairs, or similar).
- Minimum of 4 years’ experience in Quality Assurance or Regulatory Affairs within the medical device industry.
- Strong working knowledge of domestic and international medical device standards and regulations, including EU MDR and IVDR.
- Excellent written and verbal communication skills.
- Strong analytical, problem‑solving, and critical thinking abilities.
- High attention to detail and organisational skills.
- Ability to collaborate effectively within cross‑functional teams.
How to Apply
If you are interested in joining our team, please submit your CV and a covering letter outlining your suitability for the role to anash@mwe.co.uk.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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Quality Assurance and Regulatory Affairs Specialist employer: Medical Wire & Equipment
Contact Detail:
Medical Wire & Equipment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance and Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to folks in the medical device industry, especially those who work in quality assurance and regulatory affairs. LinkedIn is your best mate here; connect with people from MWE and engage with their posts to get noticed.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and IVDR regulations. We want you to show off your expertise! Think about how your past experiences align with the role and be ready to discuss specific examples.
✨Tip Number 3
Don’t just apply and wait! Follow up on your application after a week or so. A quick email to express your continued interest can set you apart from other candidates. It shows you're proactive and really keen on the role.
✨Tip Number 4
Use our website to apply directly! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining our team at MWE. Let’s make it happen!
We think you need these skills to ace Quality Assurance and Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance and Regulatory Affairs role. Highlight your relevant experience in the medical device industry and any specific knowledge of EU MDR and IVDR regulations. We want to see how your background aligns with what we do!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and regulatory affairs. Share specific examples of how you've contributed to compliance and continuous improvement in previous roles. We love a good story!
Showcase Your Skills: Don’t forget to highlight your analytical and problem-solving skills in both your CV and cover letter. We’re looking for someone who can drive initiatives and improve our Quality Management System, so make sure we see that you’ve got what it takes!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. We can’t wait to hear from you!
How to prepare for a job interview at Medical Wire & Equipment
✨Know Your Standards
Familiarise yourself with the key medical device standards and regulations, especially EU MDR and IVDR. Being able to discuss these in detail will show your expertise and commitment to quality assurance.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in Quality Assurance and Regulatory Affairs. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
✨Demonstrate Problem-Solving Skills
Be ready to discuss how you've driven continuous improvement initiatives in previous positions. Highlight any challenges you faced and how you resolved them, as this is crucial for the role.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality culture and their approach to compliance. This not only shows your interest but also helps you gauge if the company aligns with your values.