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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: A BSc in Life Sciences or related field, plus experience in regulated environments is essential.
- 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 - 40000 £ 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 will 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 will 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 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
- 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 QA Officer or have worked in the lab and have good QA/regs knowledge then please apply now.
Quality and Regulatory Specialist employer: Kenton Black
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 ISO 13485 and EU IVD Regulation 2017/746. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality management in the medical devices sector.
✨Tip Number 2
Network with professionals in the quality and regulatory field, especially those who have experience in IVD or medical devices. Attend industry events or join relevant online forums to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Brush up on your knowledge of complaint handling and CAPA processes. Being able to discuss specific examples of how you've resolved product complaints or implemented corrective actions can set you apart during discussions.
✨Tip Number 4
If you speak additional languages, particularly German or French, highlight this in conversations. It can be a significant advantage when liaising with international regulatory bodies and may give you an edge over 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 context of IVD medical devices. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about quality and regulatory compliance. Mention specific experiences that align with the responsibilities listed, such as managing product complaints or supporting regulatory submissions.
Highlight Relevant Qualifications: Clearly state your educational background and any certifications related to quality systems and regulatory frameworks. If you have experience with ISO standards, make sure to emphasise this in both your CV and cover letter.
Showcase Soft Skills: In addition to technical skills, highlight your ability to collaborate across departments and promote regulatory awareness. Provide examples of how you've worked effectively in teams or led initiatives that improved compliance or quality.
How to prepare for a job interview at Kenton Black
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 9001, and the EU IVD Regulation 2017/746. Be prepared to discuss how your experience aligns with these standards and how you can contribute to maintaining compliance.
✨Showcase Your Problem-Solving Skills
Be ready to provide examples of how you've investigated and resolved product complaints in the past. Highlight your approach to implementing corrective and preventive actions (CAPAs) effectively.
✨Demonstrate Cross-Department Collaboration
Prepare to discuss your experience working with different teams, such as R&D and QC. Emphasise your ability to manage technical documentation and regulatory files while promoting regulatory awareness across departments.
✨Highlight Your Regulatory Affairs Experience
If you have previous experience in regulatory affairs or quality assurance, make sure to bring it up. Discuss any interactions you've had with international regulatory bodies and your role in supporting global product registrations.
