• Define and execute the long-term regulatory strategy aligned with corporate growth objectives and portfolio expansion. • Architect regulatory strategies enabling independent iteration of AI algorithms distinct from core platforms, defining regulatory logic for modular systems (AI engines, reporting engines, workflow tools). • Lead regulatory assessments supporting expansion into broader clinical workflows bridging diagnostic imaging and treatment planning. • Operationalize market access beyond the U.S. (EMEA, GCC), harmonizing technical documentation under an “assess once, submit many” framework. • Establish and approve regulatory policies, standards, and governance models that ensure enterprise-wide compliance and consistency. • Serve as a key advisor to executive leadership on regulatory risk, emerging policy trends, and strategic expansion opportunities. • Lead implementation and optimization of Regulatory Information Management (RIM) systems and integration with eQMS platforms. • Develop internal regulatory intelligence capabilities leveraging AI to monitor evolving global regulations (FDA, EU MDR, EU AI Act, IMDRF) and proactively assess impact. • Ensure commercial claims remain defensible, traceable to cleared indications, and aligned with global regulatory requirements. • Establish scalable processes, KPIs, and performance metrics to enhance regulatory efficiency, transparency, and predictability. • Develop and manage departmental budgets and long-range resource planning aligned with corporate growth.