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Personalized precision heart health
Vice President, Regulatory Strategy and Innovation
Location
California + 2 moreAll locations: California | New York | Texas
Posted
112 days ago
Salary
$336K - $360K / year
Seniority
Lead
Job Description
Vice President, Regulatory Strategy and Innovation
Cleerly
• 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.
Job Requirements
- B.S. or higher degree in a Life Science, Engineering, or related discipline.
- JD preferred.
- Regulatory Affairs Certification (RAC) highly preferred.
- Minimum 15+ years of progressive Regulatory Affairs experience, including significant expertise in SaMD and AI/ML-enabled medical technologies.
- Minimum 7–10 years of leadership experience, including managing managers and multi-level teams.
- Demonstrated experience defining global regulatory strategy under EU MDR and international frameworks (including GCC markets).
- Proven record of executive engagement with global regulatory authorities.
- Deep understanding of software development lifecycle (SDLC), agile methodologies, and application of IEC 62304 and ISO 14971 within modular and AI-enabled architectures.
- Experience integrating regulatory strategy into product development and commercialization planning.
- Experience implementing or modernizing RIM, eQMS, or digital regulatory infrastructure strongly preferred.
- Strategic Foresight: Ability to synthesize complex regulatory landscapes and define clear long-term direction.
- Courageous Leadership: Navigating ambiguity in emerging AI regulations while maintaining rigorous compliance standards.
Benefits
- 20% target annual bonus
- Stock options
- Paid benefits
- Employee perks
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