Senior Manager, Regulatory Affairs

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 Opportunity

As Senior Manager, Regulatory Affairs, you will oversee regulatory activities and personnel to support Cleerly’s product development, global market access and compliance objectives. You will help contribute to Cleerly’s regulatory team in the areas of regulatory strategy, regulatory intelligence, and regulatory operations including submissions.

 

You will build a team of regulatory professionals, ensuring high-quality execution of Cleerly’s regulatory strategy, submissions; provide guidance to cross-functional teams, and adherence to evolving global regulatory requirements. This role combines hands-on regulatory expertise with leadership responsibilities, contributing to departmental strategy and talent development.  

 

You will support inspections and/or audits from health authorities, support and/or lead global regulatory and compliance initiatives and provide regulatory and compliance guidance while helping to develop, lead and manage the regulatory team.

 

Responsibilities

Digital Health & SaMD Regulatory Leadership

• Lead the regulatory strategy for Cleerly's AI and Software as a Medical Device (SaMD). This includes authoring and managing submissions for key markets (e.g., FDA 510(k), De Novo; EU CE Marking under MDR).
• You will serve as the subject matter expert on SaMD regulations, ensuring our AI/ML-powered products meet and exceed global standards for safety, efficacy, and cybersecurity.

Advanced Imaging & Technology Compliance

• Collaborate closely with R&D and product teams to ensure regulatory requirements are integrated into the design and development of our Cleerly’s software and AI medical devices.
•  Provide guidance on verification and validation activities, clinical data requirements, and usability engineering to support our product claims and intended use.

Proactive Regulatory Intelligence

• Develop and maintain a robust regulatory intelligence program to monitor, analyze, and communicate changes in the global regulatory environment.
• You will translate new regulations, guidance documents, and standards into actionable strategies, ensuring Cleerly stays ahead of the curve in areas like AI/ML transparency, data privacy, and interoperability.

Advertising & Promotional Governance

• Establish and manage the Ad Promo review process to ensure all commercial and marketing materials are compliant, truthful, and non-misleading.
• You will work cross-functionally with commercial teams to substantiate claims and align promotional activities with cleared/approved product labeling, mitigating compliance risk.

Scalable Process Management

• Drive the optimization of regulatory workflows and information systems. This includes refining submission templates, managing regulatory documentation within the Quality Management System (QMS), and implementing efficient process management tools.
• Your goal is to build a scalable and agile regulatory operations framework that supports rapid innovation.

End-to-End Regulatory Compliance: