Licenced nurse in the Philippines. An experienced professional in Intake processing, Medical Device Reporting (MDR), complaint handling, post-market surveillance, and global rules like FDA 21 CFR Part 803, EU MDR, and ISO 13485. Skilled in evaluating device-related incidents, conducting root cause analysis, and preparing regulatory submissions within required timelines.
Handles intermediate data annotation in remote AI-LLM projects. Familiar with basic medical
coding, bringing a diverse and adaptable skill set to support organizational efficiency and quality initiatives.
