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IVD Medical Device Technical Documentation Assessor
vor 3 Wochen
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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