Principal Regulatory Affairs Specialist/Engineer (SaMD)

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. 

We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Senior Regulatory Specialist must be experienced and thoughtful about the processes necessary for achieving domestic and regulatory approval. 

You'll be joining 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 manager. You will also be working daily with data scientists and medical doctors, who will help to integrate software solutions with the healthcare diagnosis 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

Key Responsibilities:

• Product Certification: Lead efforts for regulatory submissions and approvals, including FDA traditional and special 510(k) submissions, de novo requests, CE marking, and other certifications required for market entry.
• Submission Management: Develop and implement regulatory strategy to ensure advancement of product pipeline and business continuity.
• Regulatory Planning: Develop regulatory plans for devices currently commercialized, devices undergoing FDA review per TAP and Breakthrough Device Designation programs.
• Risk Management: Develop and maintain risk management processes, ensuring compliance with ISO 14971 and related standards.
• Policy Development: Establish and maintain company policies and procedures to support regulatory and quality initiatives.
• Cross-Functional Collaboration: Work closely with R&D, product, and clinical teams to integrate regulatory requirements into product development and lifecycle management.
• Audits and Inspections: Support internal and external audits, including FDA and ISO inspections, and ensure readiness for all regulatory reviews including technical files, dossiers, Medical Device DHFs, etc.
• Training and Support: Provide training and guidance to internal teams on regulatory and quality requirements.
• Continuous Improvement: Identify opportunities to enhance regulatory and quality processes, driving efficiency and compliance.
• Regulatory Intelligence: Stay current with changes in regulations, standards, and industry trends, ensuring the company remains ahead of compliance requirements.
• Escalates business critical information in relation to regulatory impact. Evaluate risk and regulatory solutions to product and clinical safety issues during clinical phases.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Draft Pre-Submission and regulatory application documents.Represent the company’s objectives and strategy while communicating with FDA and other regulatory bodies.
• Perform regulatory assessment of product changes, develop and implement processes to ensure regulatory compliance and risk based change assessments.
• Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
• Prepare, or contribute to