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- Tasks: Conduct audits of in-vitro diagnostic medical devices across the UK.
- Company: Join a leading firm in medical device regulation and quality assurance.
- Benefits: Enjoy a company car or allowance, flexible working, and professional growth opportunities.
- Why this job: Make a real impact in healthcare while developing your auditing skills in a dynamic environment.
- Qualifications: Degree in a scientific field and experience with IVDs or Quality Management Systems required.
- Other info: Field-based role with travel across the UK, perfect for those who love variety.
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.
- 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 in Birmingham employer: Kenton Black - Science & Engineering
Contact Detail:
Kenton Black - Science & Engineering Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IVD Lead Auditor in Birmingham
✨Tip Number 1
Network with professionals in the IVD and medical device industry. Attend relevant conferences, workshops, or webinars to meet potential colleagues and employers. Building relationships can often lead to job opportunities that aren't advertised.
✨Tip Number 2
Stay updated on the latest regulations and standards related to IVDs and medical devices. Familiarity with EU IVDR and ISO 13485 will not only enhance your knowledge but also demonstrate your commitment to the field during interviews.
✨Tip Number 3
Consider joining professional organisations or associations related to quality management and regulatory affairs in the medical device sector. These groups often provide resources, job boards, and networking opportunities that can help you land a role.
✨Tip Number 4
Prepare for interviews by practising common questions specific to auditing and quality management in the IVD sector. Be ready to discuss your practical experience and how it aligns with the responsibilities of the Lead Auditor role.
We think you need these skills to ace IVD Lead Auditor in Birmingham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in the design, manufacturing, or testing of IVD medical devices. Emphasise your familiarity with Quality Management Systems and any specific regulations mentioned in the job description.
Craft a Strong Cover Letter: In your cover letter, explain why you are passionate about the role of IVD Lead Auditor. Mention your practical experience and how it aligns with the responsibilities outlined in the job description, particularly your ability to conduct audits and manage customer relationships.
Highlight Relevant Qualifications: Clearly list your qualifications, especially your university degree or equivalent in a relevant scientific field. Include any certifications or training related to IVDs and Medical Device Quality Management Systems that would make you a strong candidate.
Showcase Your Knowledge of Regulations: Demonstrate your understanding of the EU IVDR and other relevant regulations in your application. You could include examples of how you've applied this knowledge in previous roles or projects, which will show your expertise in the field.
How to prepare for a job interview at Kenton Black - Science & Engineering
✨Know Your Regulations
Familiarise yourself with the EU IVDR and other relevant regulations like ISO 13485. Being able to discuss these in detail will show your expertise and understanding of the industry standards.
✨Demonstrate Audit Experience
Prepare examples from your past experiences where you successfully conducted audits or worked with Quality Management Systems. Highlight how you ensured compliance and customer satisfaction during these processes.
✨Showcase Technical Knowledge
Be ready to discuss your educational background and practical experience in IVD medical devices. This could include specific projects or roles that relate directly to the job description.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's audit processes, team dynamics, and future projects. This not only shows your interest but also helps you gauge if the company is the right fit for you.
