Vice President, Regulatory Strategy and Innovation

Overview

Cleerly is a healthcare company focused on revolutionizing how heart disease is diagnosed, treated, and tracked. The organization is building a growing team across engineering, operations, medical affairs, marketing, and sales, with remote work and some on-site locations in Denver, New York, Dallas, and Lisbon. Cleerly develops AI-driven diagnostic solutions aimed at quantifying and characterizing atherosclerosis and supporting global clinical research and regulatory requirements.

We are seeking a strategic leader to advance regulatory strategy and innovation as part of the executive team.

Vice President of Regulatory Strategy and Innovation. Report to the Chief Regulatory Officer. Define and operationalize the long-term regulatory vision for Cleerly, ensuring regulatory strategy is integrated into enterprise planning, portfolio prioritization, and global expansion. Move beyond submissions to architect the global regulatory infrastructure for a high-growth, AI-driven medical technology company. Position Regulatory Affairs as a strategic enabler of innovation, competitive differentiation, and sustainable global compliance.

• Strategic Regulatory Leadership
• 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 and 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) using a unified framework for documentation.
• Establish and govern regulatory policies, standards, and compliance models.
• Advise executive leadership on regulatory risk, trends, and expansion opportunities.
• Regulatory Operations, Digital Transformation & Intelligence
• Lead modernization of Regulatory Information Management (RIM) and integration with eQMS.
• Develop AI-enabled regulatory intelligence to monitor global regulations and assess impact.
• Ensure claims governance remains defensible and aligned with regulatory requirements.
• Establish scalable processes, KPIs, and performance metrics to enhance efficiency and predictability.
• Develop and manage departmental budgets and long-range resource planning.
• External Relations & Industry Influence
• Represent the company before global regulatory authorities on high-impact strategic matters.
• Engage in industry forums and policy discussions influencing AI/ML regulatory frameworks.
• Analyze societal, economic, and policy trends to inform regulatory and business strategy.
• Talent Strategy & Organizational Leadership
• Build and mentor a high-performing leadership team.
• Partner with HR on succession planning and capability development.
• Lead cross-functional initiatives across Regulatory, Engineering, Product, Clinical Affairs, Marketing, and Legal.
• Foster a culture of integrity, transparency, and regulatory excellence.
• Travel
• Approximately 40% travel may be required.

• Education and Certification
• B.S. or higher in Life Science, Engineering, or related field.
• Juris Doctor (JD) preferred.
• Regulatory Affairs Certification (RAC) highly preferred.
• Experience
• Minimum 15+ years in regulatory affairs, with substantial SaMD and AI/ML-enabled medical technology experience.
• Experience with Class II/III cardiovascular devices preferred.
• Minimum 7–10 years of leadership experience, including managing managers and multi-level teams.
• Proven ability to define global regulatory strategy under EU MDR and international frameworks (including GCC markets).
• Track record of executive engagement with global regulatory authorities.
• Technical Expertise
• Deep understanding of SDLC, agile methods, and application of IEC 62304 and ISO 14971 in modular/AI-enabled architectures.
• Experience integrating regulatory strategy into product development and commercialization planning.
• Experience implementing or modernizing RIM, eQMS, or digital regulatory infrastructure preferred.
• Executive Competencies
• Strategic foresight and long-term direction setting.
• Business acumen for integrating regulatory…