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Healthtech
Lead software quality and design control for SaMD and AI/ML-enabled digital health products. Manage end-to-end SDLC design controls, risk analyses (HA, FTA, FMEA), and software V&V. Ensure regulatory compliance (IEC, ISO, AAMI), maintain audit-ready DHF, support global submissions (FDA, PMDA, EU-MDR), and coach R&D on quality and compliance within an Agile SaaS environment.
