Director, Quality Systems & Regulatory Compliance

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. 

About the Team 

The mission of the Regulatory and Quality Affairs team is to empower Cleerly to bring new, safe, and effective products to market and implement a quality foundation to support a patient-focused, innovative heart care organization. Cleerly is building a best in class Regulatory and Quality team in order to establish Cleerly as a leader in SaMD and Healthcare AI. Cleerly products and services are being developed at the leading edge of AI software medical devices. We are seeking subject matter experts to join our growing team. 

About the Opportunity 

We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Director/Sr. Director of Quality Systems and Regulatory Compliance plays a pivotal role in driving the company’s quality, regulatory, and overall compliance strategy, ensuring adherence to global requirements and fostering a culture of continuous compliance excellence. You will build, manage, and lead a talented team and collaborate cross-functionally to advance our innovative cardiovascular imaging products, ensuring a safe and effective device/software. 

You will join a team that delivers at high frequency by using and creating the latest technologies, interacting constantly with your team, and communicating daily with the product team. You will also work daily with data scientists and medical doctors, who will help integrate software solutions with healthcare systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process. 

Responsibilities 

• Quality & Compliance Oversight: Own and ensure the effective implementation of quality system processes that support product quality, patient safety, and regulatory compliance across the product lifecycle.
• QMS Leadership & Strategic Development: Lead the continuous improvement and scaling of the Cleerly electronic Quality Management System (eQMS) in compliance with industry standards such as ISO 13485:2016, MDSAP, EU MDR, 21 CFR Part 820, and 21 CFR Part 803, ensuring readiness for current and future regulatory landscapes. 
• Audit Management: Plan, lead, and manage all internal and external audits, including those by Notified Bodies, the FDA and  other regulatory authorities. Ensure timely closure of audit findings and proactive mitigation of potential gaps. 
• Global Expansion Support: Develop and execute strategic quality system initiatives to support market expansion into global jurisdictions, ensuring alignment with regional regulatory expectations and certification pathways.
• CAPA & Management Review: Define, implement, and oversee a scalable Corrective and Preventive Action (CAPA) system. Facilitate effective Management Review processes to assess QMS performance, compliance trends, and continuous improvement activities.
• Continuous Improvement: Proactively identify, prioritize, and lead quality system improvements across cross-functional teams to optimize performance, reduce risk, and enhance compliance throughout the organization. 
• Risk Manageme