Key Facts

Remote From:

Full time

English

Hard Skills

Complaint Investigations Medical Device Directive Customer Complaint Resolution Cross-Functional Collaboration Process Improvement Escalation Management Customer Complaint Resolution Regulatory Compliance Technical Analysis Total Quality Management Biosensors Cardiac Devices

Other Skills

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Report Writing
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Collaboration
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Communication
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Time Management
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Teamwork
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Problem Solving

Roles & Responsibilities

Experience in quality/regulatory/compliance, preferably in medical devices or healthcare.
Knowledge of medical device reporting requirements (e.g., 21 CFR Part 803) and European Vigilance Reporting.
Strong investigative and analytical skills with ability to coordinate cross-functional investigations.
Excellent documentation, communication, and timely escalation of issues; ability to maintain logs and participate in process improvements.

Requirements:

Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports.
Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete.
Ensures issues are being addressed and escalated in a timely manner.

Job description

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:

Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.

• Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports

• Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete

• Ensures issues are being addressed and escalated in a timely manner

• Maintains complaints log.

• Participates in process improvements.

• Perform other quality and regulatory-related duties as assigned.

Location:

Manila

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 taops@irhythmtech.com

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, iRhythm’s 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 @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