Vice President, Regulatory Strategy – Innovation

Cleerly

Vice President overseeing Regulatory Strategy and Innovation for AI-driven health solutions at Cleerly. Leading global compliance and regulatory vision to scale the company’s growth.

Posted 6/2/2026full-timeCalifornia, New York, Texas • 🇺🇸 United StatesLead💰 $336,000 - $360,000 per yearWebsite

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Hard Skills

Regulatory AffairsAI algorithmsRegulatory Information Management (RIM)eQMSSoftware Development Lifecycle (SDLC)Agile methodologiesIEC 62304ISO 14971Global regulatory strategySaMD

Soft Skills

LeadershipStrategic planningCross-functional collaborationMentoringInfluencingCommunicationAnalytical thinkingProblem-solvingBudget managementSuccession planning

Tools & Technologies

Regulatory Information Management (RIM) systemseQMS platformsDigital regulatory infrastructureAI/ML technologiesClinical workflowsTechnical documentationPerformance metricsKPI developmentMarket access frameworksRegulatory compliance systems

Certifications & Qualifications

Regulatory Affairs Certification (RAC)JD

Industry Keywords

Medical devicesAI/ML-enabled technologiesEU MDRGCC marketsRegulatory strategyCompliance standardsPortfolio expansionMarket accessClinical AffairsDiagnostic imaging

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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
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
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
Serve as primary executive representative before global regulatory authorities on high-impact strategic matters
Engage in industry forums and policy discussions influencing regulatory frameworks for AI/ML-enabled medical devices
Analyze societal, economic, and policy trends to proactively inform Cleerly’s regulatory and business strategies
Build and mentor a high-performing leadership team (Directors and Senior Managers)
Partner with HR to develop succession planning, retention strategies, and executive-level capability development
Lead initiatives requiring alignment across Regulatory, Engineering, Product, Clinical Affairs, Marketing, and Legal
Reinforce a culture grounded in integrity, transparency, and regulatory excellence consistent with enterprise-level expectations

Requirements

What you’ll need

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
Ability to synthesize complex regulatory landscapes and define clear long-term direction
Integrating regulatory insights into portfolio prioritization and commercial strategy
Navigating ambiguity in emerging AI regulations while maintaining rigorous compliance standards
Ability to align and influence cross-functional and executive stakeholders
40% travel

Benefits

Comp & perks

20% target annual bonus
Stock options
Employee perks