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Vice President, Regulatory Strategy and Innovation

hace 5 días

Denver

Job Description 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.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., • 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., • 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., • 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. 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 Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

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