Director, QA Regulatory Compliance

iRhythm Technologies, Inc.

1d•$182,000 - $237,000•Remote

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
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.
Serve as senior compliance liaison with international health authorities, and notified bodies including: BSI or equivalent accredited notified bodies European Union (EU MDR, Notified Bodies, Competent Authorities) United Kingdom (UK MDR, UK Approved Bodies, MHRA) Japan (PMDA / MHLW)
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.
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