VP, Regulatory & Quality 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 will enable rapid growth and continued support of our mission. Our teams work remotely and have access to our offices in Colorado, New York, and Portugal. 

Cleerly is creating 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

The Vice President of Regulatory and Quality Affairs is a critical executive role responsible for leading, designing, and implementing the regulatory strategy and quality assurance operations to ensure compliance with global industry standards and regulatory requirements. This position involves strategic oversight of regulatory submissions, Quality Management Systems (QMS), and continuous improvement initiatives. The VP will work closely with cross-functional teams to support product development and ensure that products meet all regulatory and quality standards and drive internal adherence to those standards and guidelines. The VP will also provide critical input for risk assessment and mitigation measures. 

About the Team

The mission of the Regulatory Affairs and Quality Assurance 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 has 3 FDA cleared products and is investing in evidence generation, has access to large databases, and conducts prospective trials. We intend to submit and clear a series of new products over the next few years.

Responsibilities

Regulatory Affairs

• Lead global regulatory strategy and submissions including INDs, NDAs, BLAs, and 510(k)s in compliance with all applicable global regulatory requirements and in alignment with company goals
• Collaborate with evidence generation, technology teams, and market access to develop regulatory strategies which accelerate time to market, create maximize product value, and ensure timely approvals and clearances for products.
• Develop and maintain effective partnerships and ensure compliance to all applicable relations and standards with the FDA, EMA, ISO and other authorities
• Proactively identify regulatory risks to the company’s programs and products, develop risk mitigation plans, and lead continuous improvement initiatives that promote product safety.
• Serve as the company subject matter expert on regulatory trends and guidances, and keep company apprised of expected changes to the regulatory landscape affecting existing and future regulatory policies, regulations, and standards
• Maintain comprehensive and accurate regulatory documentation and records.
• Provide training, and interpretation of regulatory guidelines or issues to personnel

Quality Assurance

• Develop, implement, maintain, and communicate the Company’s quality strategy and programs
• Ensure products meet quality and safety standards through rigorous testing and validation processes.
• Oversee the maintenance of a fit-for-purpose quality management system (QMS)
• Create and execute a plan for ensuring a state of inspection readiness and continuous improvement, and oversee internal and external audits.
• Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained
• Establish metrics and gather information about device usage and efficiencies using available data. Interpret and present information to the Leadership Team using statistical processes.  

Leadership

• Provide support, mentorship, and guidance to reg