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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.
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