Role Summary This role drives Eko's ability to bring AI-powered cardiac and pulmonary detection tools to market globally by leading regulatory strategy across the full product lifecycle. The Director owns the overall regulatory strategy for the company and drives highly coordinated submissions and approvals (FDA, CE Mark, Health Canada, PMDA, etc.) for our SaMD and hardware portfolio, ensuring accelerated market access while maintaining compliance with evolving requirements like EU MDR and emerging AI regulations. By embedding regulatory intelligence early in product development, this leader enables innovation, mitigates business risk, and unlocks revenue growth across priority geographies transforming novel detection tools into cleared, commercially viable products that improve patient outcomes. Essential Functions Proven ability to own and drive end-to-end regulatory strategy from concept through commercialization, including portfolio prioritization and resource allocation aligned