Vice President, Regulatory Strategy – Innovation

Role Overview

• 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

• 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

Tech Stack

• SDLC

Benefits

• 20% target annual bonus
• Stock options
• Employee perks