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- Tasks: Lead global regulatory compliance and ensure quality in cardiac health solutions.
- Company: Join iRhythm, a pioneering company transforming cardiac health worldwide.
- Benefits: Competitive salary, remote work, and opportunities for professional growth.
- Why this job: Make a real impact on patient lives while advancing your career in a dynamic environment.
- Qualifications: 10+ years in regulatory compliance with strong leadership skills.
- Other info: Collaborative culture focused on innovation and continuous improvement.
The predicted salary is between 136000 - 180000 £ per year.
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:
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
- 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.
- 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.
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
- 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 frameworks.
- 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 - US
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range: $182,000.00 - $237,000.00
As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences.
Director, QA Regulatory Compliance employer: El Camino Health
Contact Detail:
El Camino Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, QA Regulatory Compliance
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We can’t stress enough how important it is to build relationships that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their products and services, especially in the cardiac health space. We want you to show genuine interest and knowledge about iRhythm during your conversations!
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the Director, QA Regulatory Compliance role. We suggest rehearsing common interview questions and your unique value proposition to stand out from the crowd.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind. And remember, apply through our website for the best chance at landing that dream job!
We think you need these skills to ace Director, QA Regulatory Compliance
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Director, QA Regulatory Compliance role. Highlight your relevant experience in regulatory compliance and leadership, and don’t forget to mention any specific interactions you've had with global health authorities.
Showcase Your Achievements: We want to see what you've accomplished! Use quantifiable results to demonstrate your impact in previous roles, especially in areas like audit readiness and compliance management. Numbers speak louder than words!
Be Clear and Concise: When writing your application, clarity is key. Avoid jargon and keep your language straightforward. We appreciate a well-structured application that gets straight to the point while still showcasing your personality.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at El Camino Health
✨Know Your Regulations
Make sure you brush up on the key regulations relevant to the role, such as 21 CFR Part 820 and ISO 13485. Being able to discuss these confidently will show that you’re not just familiar with the compliance landscape but also ready to lead in it.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams through audits or inspections in the past. Highlight your ability to influence cross-functional teams and foster a culture of compliance. This is crucial for a Director role, so be ready to demonstrate your leadership style.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to regulatory compliance challenges. Think about how you would handle issues like unexpected audit findings or cross-regional compliance discrepancies. Practising these scenarios can help you articulate your thought process clearly.
✨Communicate Clearly and Concisely
Since you'll be preparing regulatory submissions and executive briefings, practice summarising complex information into clear, actionable insights. During the interview, focus on being concise while still providing enough detail to showcase your expertise.
