IVD Medical Device Technical Documentation Assessor

vor 3 Wochen


Munich, Deutschland TÜV SÜD Vollzeit

Aufgaben

Assessing technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, most high-risk products as part of product conformity assessments according to the requirements of the IVDR

Preparing reports included deficiency reports in case of non-conformities according to the requirements of the In Vitro Diagnostic Medical Devices Regulation 2017/746

Delivering high-quality, reliable, and predictable services within defined timeframes

Serving as an internal point of contact for TDA matters as part of the interfaces with other departments, offering support of and close exchange with colleagues

Independent supervision of certification projects for our international customers as a project manager

Readiness for intensive familiarisation with the ISO 13485, ISO 9001, MDR and MDSAP standards

Optionally providing support during QMS audits of medical devices manufacturers according to ISO 13485

Possibility of attending medical conferences

Qualifikationen

University degree in a scientific studies, e.g. chemistry, biotechnology, biochemistry, bioengineering or comparable field of study (PhD is a plus)

At least four years of professional experience in the manufacturing environment of the health care sector, e.g. with a manufacturer of medical devices

At least two years of well-founded hands-on practical experience at design and development, quality management, manufacture, testing or regulatory affairs department is a plus

Experience in creating or evaluating of technical documentation including high risk medical devices with the currently applicable product standards and regulatory requirements according to IVDR

Sound knowledge of immunology, molecular biology and related techniques

Fluency in written and spoken English

Proven qualification as an auditor or quality manger is a plus

Excellent organisational and professional communication skills

Ability to work in a team, pronounced customer orientation and good self-organization

Curiosity and willingness to learn

Experience working with MS Office applications and programs



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