Vice President, Regulatory Strategy and Innovation

Cleerly•Denver, CO

8h•Remote

About The Position

Cleerly is entering a pivotal phase of growth. As we scale to a broader commercial footprint, we are seeking a Vice President of Regulatory Strategy and Innovation to serve as a strategic partner, reporting to the Chief Regulatory Officer. In this role, you will be responsible for defining and operationalizing the long-term regulatory vision for Cleerly, ensuring that regulatory strategy is fully integrated into enterprise planning, portfolio prioritization, and global expansion. You will move beyond the execution of submissions to architect the global regulatory infrastructure required for a high-growth, AI-driven medical technology company. You will position Regulatory Affairs as a strategic enabler of innovation, competitive differentiation, and sustainable global compliance.

Requirements

B.S. or higher degree in a Life Science, Engineering, or related discipline.
Minimum 15+ years of progressive Regulatory Affairs experience, including significant expertise in SaMD and AI/ML-enabled medical technologies.
Experience with Class II/III cardiovascular devices strongly preferred.
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.
Strategic Foresight: Ability to synthesize complex regulatory landscapes and define clear long-term direction.
Business Acumen: Integrating regulatory insights into portfolio prioritization and commercial strategy.
Courageous Leadership: Navigating ambiguity in emerging AI regulations while maintaining rigorous compliance standards.
Enterprise Influence: Ability to align and influence cross-functional and executive stakeholders.

Nice To Haves

JD preferred.
Regulatory Affairs Certification (RAC) highly preferred.
Experience implementing or modernizing RIM, eQMS, or digital regulatory infrastructure strongly preferred.

Responsibilities

Strategic Regulatory Leadership
Enterprise Vision: Define and execute the long-term regulatory strategy aligned with corporate growth objectives and portfolio expansion.
Portfolio Architecture: 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).
New Clinical Frontiers: Lead regulatory assessments supporting expansion into broader clinical workflows bridging diagnostic imaging and treatment planning.
Global Market Strategy: Operationalize market access beyond the U.S. (EMEA, GCC), harmonizing technical documentation under an “assess once, submit many” framework.
Policy & Governance Ownership: Establish and approve regulatory policies, standards, and governance models that ensure enterprise-wide compliance and consistency.
Executive Advisory Role: Serve as a key advisor to executive leadership on regulatory risk, emerging policy trends, and strategic expansion opportunities..
Regulatory Operations, Digital Transformation & Intelligence
Regulatory Infrastructure Modernization: Lead implementation and optimization of Regulatory Information Management (RIM) systems and integration with eQMS platforms.
AI-Enabled Regulatory Intelligence: Develop internal regulatory intelligence capabilities leveraging AI to monitor evolving global regulations (FDA, EU MDR, EU AI Act, IMDRF) and proactively assess impact.
Claims Governance: Ensure commercial claims remain defensible, traceable to cleared indications, and aligned with global regulatory requirements.
Continuous Improvement: Establish scalable processes, KPIs, and performance metrics to enhance regulatory efficiency, transparency, and predictability.
Budget & Resource Stewardship: Develop and manage departmental budgets and long-range resource planning aligned with corporate growth.
External Relations & Industry Influence
Health Authority Engagement: Serve as primary executive representative before global regulatory authorities on high-impact strategic matters.
Industry Leadership: Engage in industry forums and policy discussions influencing regulatory frameworks for AI/ML-enabled medical devices.
Regulatory Foresight: Analyze societal, economic, and policy trends to proactively inform Cleerly’s regulatory and business strategies.
Talent Strategy & Organizational Leadership
Organizational Development: Build and mentor a high-performing leadership team (Directors and Senior Managers).
Talent Strategy: Partner with HR to develop succession planning, retention strategies, and executive-level capability development.
Cross-Functional Enterprise Leadership: Lead initiatives requiring alignment across Regulatory, Engineering, Product, Clinical Affairs, Marketing, and Legal.
Culture of Ethical Leadership: Reinforce a culture grounded in integrity, transparency, and regulatory excellence consistent with enterprise-level expectations.