This job offer is not available in your country. Description. Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements. Identifies, analyzes and implements country specific requirements necessary for product related submissions. Recommend strategies for earliest possible approvals for marketing applications. Performs regulatory projects or acts as a memb...
Job Details. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches. Product Registration Experience. Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files. Knowledge of regulatory guidance documents and ...
