Qa Manager And Prrc In Ivd Product
- Development, implementation and maintenance of a Quality Management System according to ISO 13485:2018 for In Vitro Diagnostic Medical Devices- Defence of ISO 13485:2018 certification audits and inspections by Competent Authorities.- Management of the process of adapting to the requirements of the new EU Regulation 2017:746 on In Vitro Diagnostic Medical Devices (CE marking of IVD products) - Preparation of documentation submissions to competent authorities- Preparation and review of technical documentation of IVD products (IFUs, labels, SDS)- Product risk management according to ISO 14971- Management and coordination of a laboratory team (4 persons) for the optimisation of monoclonal antibodies for in vitro diagnostics.- Supervision of manufacturing, import and marketing activities.- Claims management and technical support to customers- Determination of KPIs and process risk management