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 position
Education, 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).

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