Director, QA Regulatory Compliance

Career-defining. Life-changing.

At iRhythm youll 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 whats 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:

Location: Cypress CA or San Francisco CA

The Director Regulatory Compliance will provide strategic leadership and operational oversight for iRhythms 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 iRhythms 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 iRhythms 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:

• 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.

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:

Actual compensation may vary depending on job-related factors including knowledge skills experience and work location.

Estimated Pay Range

As 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

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect predict and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care iRhythms vision is to deliver better data better insights and better health for all.

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 @ email address. Please check any communications to be sure they come directly from @ 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 Written offers of employment will be extended in a formal offer letter from an @ email address ONLY.

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Director