We are seeking an experienced IVDR Lead Auditor to conduct regulatory audits, ensuring compliance with EU IVDR 2017/746 and other relevant quality standards.

This role involves working closely with manufacturers, assessing technical documentation, and ensuring conformity to regulatory requirements.

The position requires a strong background in in vitro diagnostic medical devices (IVDs) and experience within a Notified Body or a similar regulatory environment.

Responsibilities Conduct IVDR audits at client sites and remotely, ensuring compliance with EU regulations and ISO 13485.

Assess technical documentation, clinical evidence, and performance evaluation data for IVD products.

Provide expert regulatory guidance to clients, supporting their IVDR certification and regulatory submissions.

Prepare detailed audit reports and maintain compliance records in line with Notified Body requirements.

Collaborate with internal teams and regulatory bodies to stay up to date with changing IVDR requirements.

Support post-market surveillance activities and ensure compliance with quality management systems (QMS).

Deliver training and guidance on IVDR compliance to internal teams and external stakeholders.

Qualifications Bachelor’s or Master’s degree in Biology, Biotechnology, Biochemistry, Biomedical Engineering, or a related field.

Minimum of four years of professional experience in IVD product design, development, manufacturing, or testing.

At least two years of experience in quality assurance, regulatory affairs, or auditing in the IVD sector.

Strong knowledge of EU IVDR 2017/746, ISO 13485, and other relevant regulatory frameworks.

Previous Notified Body experience is highly desirable.

IRCA Lead Auditor certification or equivalent is a plus.

Ability to manage audits independently and work with cross-functional teams.

Excellent verbal and written communication skills in English; additional European languages are a plus.

Willingness to travel as required.