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- Tasks: Plan and conduct audits of in-vitro diagnostic medical devices across the UK.
- Company: Join a leading firm in the medical device industry, committed to quality and compliance.
- Benefits: Enjoy a company car or allowance, flexible working, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while developing your skills in a dynamic environment.
- Qualifications: Degree in a relevant scientific field and experience in IVDs or Quality Management Systems required.
- Other info: Field-based role with travel across the UK; perfect for those who love variety in their work.
The predicted salary is between 36000 - 60000 £ per year.
Location: Field-based (UK)
Travel: Primarily within the UK (Company car or car allowance provided)
Our client is looking to recruit an Invitro Diagnostics Lead Auditor to plan and conduct audits of in-vitro diagnostic medical devices to EU IVDR (EU Regulation 2017/746).
Key Responsibilities:
- Conduct on-site audits for clients using established procedures, delivering high-quality service that fosters strong customer relationships.
- Work independently or lead audit teams, ensuring customer satisfaction and compliance with industry standards and regulatory requirements.
- Complete all audits and tasks within the set budget and time constraints.
- Undertake specific projects related to medical device processes, systems, documentation, and procedures, as assigned by the Medical Devices Manager.
Qualifications:
- Practical experience in the design, manufacturing, or testing of IVD medical devices, with experience in Quality Management System (QMS) or in Quality Management/Regulatory Affairs.
- A university degree or equivalent qualification in a relevant scientific field, such as: Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science, Biomedical Engineering, Mechanical, Electrical, or Electronic Engineering, or Computer & Software Technology.
- Familiarity with IVDs and Medical Devices (active, non-active, or software-based) and Medical Device Quality Management Systems.
- In-depth knowledge of EU IVD Directive 98/79/EC, EU IVD Regulation 2017/746, EU Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745, UK Medical Device Regulation, and ISO 13485.
- Understanding of relevant IVD and Medical Device Standards.
IVD Lead Auditor employer: Kenton Black Ltd
Contact Detail:
Kenton Black Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IVD Lead Auditor
✨Tip Number 1
Network with professionals in the IVD and medical device industry. Attend relevant conferences, workshops, or webinars to meet potential colleagues and learn about the latest trends. This can help you gain insights into the role and make valuable connections.
✨Tip Number 2
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as EU IVDR and ISO 13485. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Consider reaching out to current or former employees of the company for informational interviews. They can provide you with insider knowledge about the company culture and expectations, which can be invaluable when preparing for your interview.
✨Tip Number 4
Prepare for potential scenario-based questions that may arise during the interview. Think about how you would handle specific audit situations or challenges related to IVDs, as this will showcase your problem-solving skills and practical experience.
We think you need these skills to ace IVD Lead Auditor
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the IVD Lead Auditor position. Familiarise yourself with the relevant regulations and standards mentioned in the job description.
Tailor Your CV: Customise your CV to highlight your experience in the design, manufacturing, or testing of IVD medical devices. Emphasise any relevant qualifications and your familiarity with Quality Management Systems and regulatory affairs.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and your understanding of the industry. Mention specific experiences that demonstrate your ability to conduct audits and maintain compliance with industry standards.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail.
How to prepare for a job interview at Kenton Black Ltd
✨Know Your Regulations
Familiarise yourself with the EU IVDR and other relevant regulations before the interview. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the industry.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in auditing, quality management systems, or working with IVD medical devices. This will help illustrate your qualifications and how they align with the role.
✨Demonstrate Problem-Solving Skills
Be ready to discuss how you've handled challenges in previous audits or projects. Employers value candidates who can think critically and adapt to changing situations, especially in a field as regulated as medical devices.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's audit processes, team dynamics, and future projects. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
