Vice President, Regulatory Strategy and Innovation

About the Opportunity

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.

About the Team

You will join a high-performing RA/QA organization transitioning from a submission-focused model to a strategy-led, enterprise-integrated function. We navigate novel regulatory pathways for AI-enabled diagnostic and interventional planning tools deployed in high-stakes clinical environments.

The Regulatory function at Cleerly plays a central role in shaping product strategy, risk management, claims governance, and global market access. This position will further elevate Regulatory as a proactive, forward-looking function aligned with the RAPS Regulatory Competency Framework and executive-level leadership expectations.

Position Summary

As Vice President, Regulatory Strategy and Innovation, reporting to the Chief Regulatory Officer, you are accountable for defining the enterprise-wide regulatory strategy and ensuring sustained global compliance across Cleerly’s product portfolio.

You will lead the evolution of Regulatory Affairs from a high-performing operational team to a digitally enabled, intelligence-driven strategic function. This includes establishing scalable systems, modern regulatory infrastructure, and forward-looking governance models that support AI innovation, modular software architectures, and global expansion.

This role operates at the functional leadership level, with direct impact on Cleerly’s competitive positioning, enterprise risk posture, and long-term market strategy

Core 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.

Requirements

• Education and Certification
• B.S. or higher degree in a Life Science, Engineering, or related discipline.
• JD preferred.
• Regulatory Affairs Certification (RAC) highly preferred.
• Experience
• 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.
• Technical Expertise
• 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.
• Executive Competencies
• 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.
• 40% travel 

Compensation

The base salary range for this role varies by location and is aligned to market benchmarks. Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range. Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 20% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $280,000 - $300,000
• TTC: $336,000 - $360,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.