IVDR Lead Auditor

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.