Director, Quality Systems & Regulatory Compliance

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 Management: Establish and maintain a risk management framework aligned with ISO 14971, ensuring integration across product development, postmarket surveillance, and design changes.
• Software Quality & Lifecycle Management: Ensure that software development, maintenance, and release activities align with IEC 62304. Drive adoption of software quality best practices tailored for SaMD and AI-based technologies.
• SaMD AI QMS Leadership: Champion the development, implementation, and evolution of a best-in-class, scalable QMS that meets the unique needs of SaMD and AI/ML-enabled products, including connectivity, data handling, and algorithm change control.
• Team Leadership & Development: Build, lead, and mentor a high-performing Quality Systems and Compliance team. Foster a culture of accountability, professional development, and operational excellence.
• Effectively partner with R&D/Engineering to define work and solve technical issues.
• ● Cross-Functional Collaboration: Ensure compliant execution of design and development activities, including software development, verification, validation, and design transfer, in accordance with IEC 62304, ISO 13485, and applicable regulatory requirements.
• CRB & Postmarket Surveillance Leadership: Chair the Complaint Review Board (CRB) and oversee complaint handling, field actions, and CAPA activities, ensuring timely investigation and closure.
• Executive Communication & Reporting: Deliver clear, data-driven reports and strategic insights to the Executive Leadership Team, identifying trends, risks, and opportunities related to quality and compliance.
• Resource Planning: Assess and allocate resources to support quality initiatives effectively, ensuring appropriate staffing and competency alignment with business and regulatory needs.
• Field Quality & Prevention: Identify systemic quality issues and lead cross-functional initiatives to mitigate recurrence. Drive preventive strategies to improve product and process robustness in future development programs.
• Standards Compliance: Lead the development and execution of a proactive standards compliance program by monitoring, interpreting, and applying evolving regulatory and industry standards to ensure Cleerly's quality systems and practices remain current, robust, and aligned with global requirements.

Requirements

• Education:Bachelor's degree in Engineering, Life Sciences, or a related technical discipline; advanced degree preferred
• Certifications
• Certified Lead Auditor for ISO 13485 or MDSAP (required or strong preference)
• ASQ Certified Quality Engineer (preferred)
• Lean Six Sigma Black Belt certification or equivalent experience (preferred)
• Experience
• 15+ years of medical device industry experience or regulated industry.
• Strong leadership and managerial skills with a minimum of 5 years of experience in leading and developing teams.
• Experience in multiple site leadership.
• Experience in supporting 3rd party audits and inspections (FDA, Notified Bodies, MDSAP, etc.).
• Technical Knowledge
• Deep understanding of relevant international standards and regulations, including: 21 CFR Part 820 (QSR), IEC 62304 (software lifecycle), ISO 13485 (QMS), ISO 14971 (risk management), ISO 62366-1 (usability engineering)
• Familiarity with AI/ML-enabled SaMD, cloud-connected systems, or digital health platforms is a plus

Skills & Abilities

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and influence stakeholders.
• Excellent command of the English language; ability to draft and revise documents with consistency of format and language; Mac and Google apps proficient.
• Strong technical presentation skills.
• Ability to remain organized and productive in a fast-paced work environment with competing priorities.
• Be a self-starter, work independently, diligently, and efficiently on assigned tasks and projects.
• Collaborate seamlessly with colleagues from other technical teams.

Salary: NYC: $265,000 - $284,000 Denver: $241,000 - $258,000

• Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.