Director, QA Regulatory Compliance
 iRhythm Technologies, Inc. | |
 United States | |
 Feb 03, 2026 | |
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Career-defining. Life-changing. At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career About This Role: Position: Director, QA Regulatory Compliance Reports to: SVP Quality & Regulatory Location: Remote, iSF, iOC The Director, Regulatory Compliance will provide strategic leadership and operational oversight for iRhythm's global regulatory compliance programs, ensuring sustained compliance across medical device, Software as a Medical Device (SaMD), digital health, and diagnostic service operations, including applicable FDA, international, and healthcare accreditation requirements. This role will serve as a key member of the Quality & Regulatory Leadership Team and a trusted partner to cross-functional leaders, demonstrating enterprise thinking, inclusive leadership, and a strong sense of ownership and accountability. Key Responsibilities include, but are not limited to: Regulatory Compliance & Inspection Leadership * Provide regulatory compliance leadership, expertise, and direction to iRhythm teams during U.S. and international regulatory audits and inspections, including FDA, EU Notified Bodies, UK Approved Bodies, Japan PMDA/MHLW, and other global health authorities. * Lead and host regulatory inspections and audits, serving as the primary company representative for FDA and other global health authority inspections, including EU Notified Bodies, UK Approved Bodies, and Japan PMDA/MHLW. * Plan, coordinate, and execute end-to-end inspection hosting activities, including pre-inspection readiness, agenda development, logistics, inspector engagement, real-time issue management, and post-inspection follow-up. * Lead organizational readiness for announced and unannounced inspections, fostering a culture of preparedness, transparency, and shared responsibility. * Serve as a strategic advisor and thought partner to senior leadership on evolving global regulatory requirements and their impact on iRhythm's products, software platforms, and diagnostic services. * Influence outcomes through collaboration and data-driven recommendations, even in complex, matrixed environments. FDA & Remediation Compliance Engagement * Serve as the QA project leader for FDA enforcement actions, including Form FDA 483 observations, Warning Letters, Untitled Letters, and regulatory commitments, demonstrating decisive leadership, accountability, and follow-through. * Support the development, execution, and governance of FDA remediation and Warning Letter resolution programs, aligning cross-functional teams around clear priorities, timelines, and success metrics. * Author, review, and approve FDA inspection responses, ensuring responses are clear, comprehensive, scientifically sound, and reflect iRhythm's commitment to quality and patient safety. * Coach and support leaders and teams through high-pressure remediation activities, reinforcing learning and resilience. Global Regulatory Compliance Authority & Engagement * Serve as senior compliance liaison with international health authorities, and notified bodies including:
* Lead responses to international inspection findings and nonconformities, aligning global teams through clear communication, mutual accountability, and consistent expectations. * Oversee remediation activities arising from EU MDR, UK MDR, and PMDA inspections, ensuring alignment across regions while respecting local regulatory nuances. * Build and maintain strong, respectful working relationships with global regulatory bodies to enable efficient issue resolution and long-term credibility. * Ensure QMS compliance with applicable regulations and standards, including 21 CFR Part 820 (QSR/QMSR), ISO 13485, ISO 14971, EU MDR, UK MDR, and Japan requirements. Audit Programs, Metrics & Governance * Lead and continuously improve internal and external audit programs, emphasizing consistency, professionalism, and readiness. * Proactively identify, assess, and communicate regulatory and compliance risks, enabling informed, timely decision-making. * Establish and maintain meaningful compliance metrics and dashboards, translating complex data into actionable insights for leaders. * Establish remediation governance frameworks that promote clarity, transparency, and ownership at all levels. * Partner closely with Quality, Regulatory Affairs, R&D, Software Engineering, IT, Data Science, Operations, and Clinical teams, influencing without authority and fostering trust-based collaboration. * Provide regular clear, concise, and actionable updates to executive leadership regarding global compliance status, remediation progress, and emerging risks. * Lead change management initiatives that embed regulatory expectations into everyday behaviors, systems, and decision-making. * Build, mentor, and develop compliance professionals, empowering teams to grow, lead, and deliver results. * Support compliance requirements applicable to Independent Diagnostic Testing Facilities (IDTFs), collaborating effectively with clinical and operations leaders. * Partner with stakeholders to support compliance with Joint Commission (TJC) standards and other applicable healthcare accreditation requirements. * Perform other related duties as assigned Basic Qualifications * B.A. / B.S. and 10+ years of experience in industry or combined industry and research M.A. / M.S. and 8+ years of experience in industry or combined industry and research Preferred Qualifications * Demonstrated leadership in FDA remediation and enforcement resolution, including successful oversight of Warning Letter responses, remediation effectiveness, and follow-up inspections. * Experience engaging directly with U.S. FDA, including inspection responses, remediation planning, status reporting, and re-inspection preparedness. * Global regulatory compliance experience, including interaction with EU MDR (Notified Bodies / Competent Authorities), UK MDR/MHRA, and Japan PMDA, with demonstrated ability to lead cross-regional regulatory activities. * Proven experience influencing cross-functional teams in a matrixed organization, including Quality, Regulatory Affairs, R&D, Software Engineering, Operations, Clinical, and IT stakeholders. * Strong knowledge of 21 CFR Part 820 (QSR/QMSR), ISO 13485, ISO 14971, EU MDR, UK MDR regulations, and global post-market surveillance and vigilance requirements applicable to device and software products. * Experience with SaMD compliance requirements, including software lifecycle and validation, cybersecurity considerations, cloud-based deployments, and AI/ML-enabled technologies. * Demonstrated success building and sustaining inspection-ready cultures through audit readiness programs, inspection readiness programs, training, CAPA, and compliance risk management frame works * Proven ability to lead and develop high-performing teams, coach and influence across all levels of the organization, and drive organizational change. * Excellent written and verbal communication skills, with experience preparing regulatory submissions, inspection responses, executive-level briefings, and cross-functional presentations. * Strong analytical, strategic thinking, and problem-solving skills, with the ability to translate complex regulatory requirements into actionable plans. * Experience working in a matrixed organization, leading through influence across stakeholders (Research & Early Development, Product Development, Commercial and Manufacturing Science & Technology) * Ability to travel up to 30% globally Location: Remote - USActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range $182,000.00 - $237,000.00As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com About iRhythm Technologies Make iRhythm your path forward. Zio, the heart monitor that changed the game. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY. For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121 | |