Vice President, Regulatory Strategy and Innovation

About the role

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. 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

Benefits

Additional Information

About Cleerly We're Cleerly - a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. Cleerly is committed to providing safe and effective medical software that meets customer needs and our intended use. The adherence to all applicable regulatory and statutory requirements establishes a clear framework for setting measurable quality objectives. Our commitment to continually improving our products and processes proactively manages risks, ensuring ongoing compliance throughout the entire software lifecycle. Understanding this role's relevance and importance is critical to achieving Cleerly's quality objectives.

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