IVD Lead Auditor

Job Title: IVD Lead Auditor

Location: Field-based (UK) - Needs to be based Midlands/South of the UK/Home Counties

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.