Director, Global Regulatory Affairs - Intelligence

Responsibilities 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. Proven ability to own and drive end-to-end regulatory strategy from concept through commercialization, including portfolio prioritization and resource allocation aligned with business goals. Lead and execute regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly authoring technical documentation and managing agency interactions (e.g., interactive responses and presubmission meetings) to secure timely approvals. Serve as the regulatory lead for the company, managing all interactions with regulatory authorities including pre-submissions, responses to deficiencies, inspections, and ongoing correspondence. Partner with cross‑functional teams (R&D, Clinical, Quality, Product, Commercial) to define and proactively embed regulatory requirements into product development workflows and align global market access strategies with business priorities. Collaborate with Head of Quality to ensure the Quality Management System represents state‑of‑the‑art practices and supports regulatory compliance and post‑market surveillance programs. Establish and lead a proactive regulatory intelligence program to monitor evolving global requirements (EU MDR, EU AI Act, FDA SaMD guidance, IMDRF standards), provide and implement strategic recommendations to executive leadership on product roadmap, risk mitigation, and competitive positioning. Build and mentor a high-performing regulatory team while driving the continuous optimization of internal workflows and submission processes, establishing scalable processes that support rapid portfolio expansion while maintaining compliance excellence. Ensure compliance with company policies and applicable laws across all regulatory activities, including adverse event reporting, clinical studies and evaluations, and labeling requirements. Requirements Bachelor's degree in a STEM field (Engineering, Life Sciences, or related discipline); advanced degree preferred 10+ years of progressive regulatory affairs experience with Class II medical devices and Software as a Medical Device (SaMD), including hands‑on submission authorship and successful FDA and international approvals (must provide specific K numbers) Deep expertise in global regulatory frameworks (FDA 510(k)/De Novo, EU MDR, ISO 13485, MDSAP) and demonstrated ability to navigate complex, multi‑jurisdictional pathways Proven track record managing regulatory authority interactions, including pre‑submission meetings, deficiency responses, and regulatory inspections with favorable outcomes Strategic regulatory intelligence capabilities with ability to translate emerging requirements (AI/ML regulations, cybersecurity guidance) into actionable business recommendations Experience leading small but mighty regulatory teams in fast‑paced, innovation‑driven environments with rapidly evolving product portfolios Proficiency with regulatory information management systems, quality management software (e.g., Veeva Vault, MasterControl, Greenlight Guru), and submission platforms (eSTAR, EUDAMED) Strong communication, organizational, and problem‑solving skills with ability to influence cross‑functional stakeholders and present complex regulatory strategy to executive leadership Great track record of successful teaming and contributing meaningfully to company culture Ability to perform the essential functions of the role with or without reasonable accommodation. #J-18808-Ljbffr Jobtailor