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- Tasks: Join us as a Quality and Regulatory Specialist, ensuring compliance and enhancing our Quality Management System.
- Company: Be part of a global leader in medical devices, making a real impact in healthcare.
- Benefits: Enjoy a competitive salary up to £40,000 and extensive benefits, including potential travel opportunities.
- Why this job: This role offers a chance to collaborate across departments and contribute to meaningful improvements in healthcare.
- Qualifications: You need a BSc in Life Sciences and experience in regulated environments, especially with IVDR expertise.
- Other info: Fluency in additional languages like German or French is a plus; applicants must have the right to work in the UK.
The predicted salary is between 32000 - 48000 £ per year.
My client, a global medical devices company, has a rare opportunity for a Quality and Regulatory Specialist to join them. As a Quality and Regulatory Specialist, you’ll play a key role in maintaining and enhancing the Quality Management System, ensuring compliance with international standards and regulations for in vitro diagnostic (IVD) medical devices. You’ll collaborate across departments, support regulatory submissions, manage product complaints, and contribute to continuous improvement initiatives.
What you’ll do:
- Support the QA/QARA Managers in maintaining compliance with ISO 13485, ISO 9001, and EU IVD Regulation 2017/746
- Investigate and resolve product complaints, ensuring timely and effective CAPAs
- Assist with internal audits, document control, supplier approvals, and regulatory submissions
- Liaise with international regulatory bodies and support global product registrations
- Collaborate with R&D and QC teams to manage technical documentation and regulatory files
- Promote regulatory awareness and best practices across the business
The ideal candidate for the Quality and Regulatory Specialist will have:
- A BSc degree or equivalent in Life Sciences, Microbiology, Biomedical Sciences, or related field
- Experience in a laboratory or regulated environment (IVD, medical devices, pharma)
- Strong understanding of quality systems and regulatory frameworks - MUST HAVE IVDR regulatory expertise
- Experience with ISO 13485, ISO 17025, or ISO 9001
- Previous regulatory affairs or QA experience
- Knowledge of document control systems
- Additional languages (especially German or French)
- Willingness to travel to our subsidiaries in Germany and France
PLEASE NOTE: Applicants must have the right to work in the UK. My client is unable to sponsor or take over sponsorship of an employment Visa at this time.
If you are an experienced Regulatory Affairs candidate with IVDR regulatory expertise then please apply now!
Contact Detail:
Kenton Black Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Regulatory Specialist
✨Tip Number 1
Familiarise yourself with the latest updates on ISO 13485 and EU IVD Regulation 2017/746. Being well-versed in these standards will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the medical devices industry, especially those who have experience in regulatory affairs. Attend relevant conferences or webinars to make connections and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled product complaints or CAPAs in previous roles. This practical experience is crucial for a Quality and Regulatory Specialist and will help you stand out during the interview process.
✨Tip Number 4
If you speak additional languages, particularly German or French, be sure to highlight this in conversations. It can be a significant advantage when liaising with international regulatory bodies and may set you apart from other candidates.
We think you need these skills to ace Quality and Regulatory Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management and regulatory affairs, particularly in the IVD or medical devices sector. Emphasise your understanding of ISO standards and any specific regulatory expertise you possess.
Craft a Compelling Cover Letter: Write a cover letter that directly addresses the key responsibilities mentioned in the job description. Showcase your experience with CAPAs, internal audits, and collaboration with cross-functional teams to demonstrate your fit for the role.
Highlight Relevant Qualifications: Clearly state your educational background, especially if you have a BSc in Life Sciences or related fields. Mention any additional qualifications or certifications that are relevant to quality and regulatory affairs.
Showcase Language Skills: If you speak additional languages, particularly German or French, make sure to highlight this in your application. It can be a significant advantage when liaising with international regulatory bodies.
How to prepare for a job interview at Kenton Black
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of ISO 13485, ISO 9001, and the EU IVD Regulation 2017/746 during the interview. Be prepared to discuss how you've applied these standards in previous roles, as this will demonstrate your expertise and relevance for the position.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills, especially regarding product complaints and CAPAs. Think of specific examples from your past experience where you successfully resolved issues or improved processes, as this will showcase your practical knowledge.
✨Emphasise Collaboration Skills
Since the role involves working with various departments, be ready to discuss your experience collaborating with R&D, QC teams, and regulatory bodies. Share examples of how you’ve effectively communicated and worked together to achieve compliance and quality goals.
✨Demonstrate Continuous Improvement Mindset
Talk about any initiatives you've led or participated in that focused on continuous improvement within quality management systems. This could include audits, training sessions, or process enhancements, which will show your proactive approach to maintaining high standards.
