E-ICR and Technical file assessor for IVD products (f/m/d)

TUV SUD
TUV SUD

IT

Posted 6+ months ago

Your tasks

Evaluation of technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, mostly class D products for blood grouping

Writing technical reports and interaction with international clients

Supporting the entire certification project through pro-active problem-solving and effective management of internal interfaces

Collaboration in an international team for technical assessment of national and interna-tional clients

Your qualifications

Completed master&;s degree in a scientific field, e.g. biology, biochemistry or biotechnolo-gy (PhD is a plus)

At least four years of professional experience in the diagnostics industry with blood grouping products (e.g. AB0, Rhesus), particularly in design and development

Sound knowledge of immunology, molecular biology and related techniques

Strong English language skills as well as routine handling of MS Office applications

Enthusiasm, passion and good self-management skills