Medical Safety and Complaints Manager
Medical Safety and Complaints Manager
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Job Description
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:
We are a mission-driven company redefining whats possible in cardiac care. As we continue to scale were seeking a clinically astute and strategic Manager Medical Safety and Complaintsan experienced Nurse Practitioner (NP) in cardiology or electrophysiologyto lead a high-performing team responsible for post-market surveillance complaint evaluation and patient safety initiatives.
Reporting into medical leadership youll play a critical role in ensuring that every product experience is assessed through a clinical lens with the goal of improving outcomes enhancing patient trust and meeting global regulatory expectations.
What Youll Do
Lead & Develop Clinical Talent: Manage a growing team of RNs and other clinical professionals responsible for complaint review clinical investigations and reportability assessments.
Provide Clinical Oversight: Review and sign off on complex or high-risk cases ensuring consistent application of clinical judgment and regulatory standards.
Drive Operational Excellence: Optimize workflows complaint handling processes and documentation standards to support efficient and compliant safety operations.
Partner Cross-Functionally: Serve as a key liaison to Quality Regulatory Affairs Product and R&D teamsensuring clinical clarity and safety strategy alignment across functions.
Enhance Safety Signal Detection: Lead clinical trending and signal detection efforts by interpreting complaint and surveillance data through a cardiology-focused lens.
Advance Clinical Strategy: Contribute to strategic safety initiatives including risk/benefit assessments labeling updates and design feedback loops.
Champion Education & Consistency: Provide training mentorship and clinical frameworks for decision-making to ensure high-quality outputs and professional growth within the team.
Support Regulatory Interactions: Collaborate with Regulatory Affairs to support inspections audits and safety-related inquiries from authorities such as the FDA and global health agencies.
About You
Clinical Credentials: Licensed NP with cardiology or electrophysiology specialization. Masters or Doctorate in Nursing preferred.
Experience: 7 years of clinical experience including direct care in cardiac populations. At least 35 years in medical device safety complaints handling or clinical quality leadership roles.
Leadership Ability: Prior experience mentoring or managing clinical teams in a regulated healthcare or MedTech setting.
Regulatory Fluency: Strong knowledge of 21 CFR 803/820 ISO 13485 MEDDEV 2.12/1 and global post-market surveillance requirements.
Strategic Thinking: Proven ability to connect day-to-day complaint management with long-term safety strategy and product improvement.
Communication Skills: Strong written and verbal communicator capable of interfacing with clinical and technical audiences alike.
Collaborative Spirit: You value partnerships across disciplines and bring a thoughtful team-first approach to problem solving.
Mission-Driven: You are committed to improving patient safety and care quality and thrive in a fast-paced high-impact environment.
Youll Love This Role If You:
Are a clinical leader who wants to shape safety practices across a category-defining product portfolio.
Want to elevate clinical decision-making within a growing and empowered team.
See medical safety as a strategic assetnot just a regulatory requirement.
Thrive at the intersection of clinical care technology and innovation.
Join us in setting a new standard for post-market medical vigilance in digital health and cardiac monitoring.
Apply now to lead with purpose and make a difference where it truly matters.
Location:
Remote - USActual compensation may vary depending on job-related factors including knowledge skills experience and work location.
Estimated Pay Range
$112000.00 - $145000.00As 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
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.
For more information see and Experience:
Manager
Employment Type
Full-Time
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