Ivdr Regulatory Affairs Trainee - (Qf-170)

Promotes a culture of quality by educating others in quality management system fundamentals, programs, and tools.- Monitors in collaboration with procurement team the compliance readiness of suppliers of commercial CE-IVD devices with IVDR.- Contributes to the continuous improvement: indicators and dashboards, implementation, and monitoring of preventive and corrective actions during IVDR Implementation project.- Provides support on the implementation of the risk management procedure in all laboratories.- Supports Quality Management activities and training related to new procedures design and maintenance, contributing to the continuous improvement culture.- Provides support, under PMO supervision, on the activities related to the implementation of the European In-Vitro Diagnostic Regulation (IVDR) in all laboratories.- Regulatory Intelligence follow up.- Performs other duties as assigned.Organization- Reporting line: IVDR Regulatory Affairs Manager- Location: Barcelona Full time positionEducation, Experience and Skills- Bachelor's degree or master's degree in technical/process engineering/QA/ Medical Device discipline, with significant related professional experience within the laboratory environment.- Ideally experience with medical device regulation and/or in-vitro diagnostic directive regulation.- Demonstrated ability to affect change.- Excellent interpersonal, organizational & communication skills with excellent attention to detail.- Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.- Responsive problem solver and action oriented.- English fluent as a must (presenting, writing, reading).
#J-18808-Ljbffr