iRhythm Technologies
Healthcare
PostMarketComplaintSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Post Market Complaint Specialist at iRhythm Technologies. Skills: Complaint handling, Regulatory compliance. Receive customer complaints. Log customer complaints”
What You'll Achieve.
Enhance product quality; Enhance patient safety
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
Complaint handling procedures per ISO 13485, 21 CFR 820.198, EU MDR
What You'll Do.
Receive customer complaints
Log customer complaints
Acknowledge customer complaints
Review complaint information
Conduct investigations
Document complaint records
How You'll Work.
Team & Collaboration
Quality Engineering; Manufacturing; R&D teams
Full 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:** The Complaint Handling Specialist is responsible for the intake, evaluation, investigation, documentation, and closure of product complaints in compliance with internal procedures and regulatory requirements. This role ensures timely and accurate processing of complaints, supports root cause analysis, and collaborates with cross-functional teams to drive corrective and preventive actions that enhance product quality and patient safety. \--- Key Responsibilities Complaint Management Receive, log, and acknowledge customer complaints within established timelines. Review complaint information for completeness, accuracy, and classification (e.g., reportable vs. non-reportable). Conduct detailed investigations, including root cause determination, in coordination with Quality Engineering, Manufacturing, and R&D teams. Ensure complaint records are properly documented in the electronic Quality Management System (eQMS). Maintain compliance with complaint handling procedures per ISO 13485, 21 CFR 820.198, and EU MDR. **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 accordan
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