Doctor for Travel Assistance Insurance based in Madrid. Fluent in English and Spanish.

Sé de los primeros solicitantes.
Iris Global Soluciones
Comunidad Valenciana
EUR 70.000 - 90.000
Sé de los primeros solicitantes.
Hace 3 días
Descripción del empleo

Descripción del trabajo

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.
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