Element Science
Product Complaint Manager
Redwood City, CA · Mid · Contract
Sponsorship not specified$135k-$160kDetected 10 days ago
AlgorithmsFDA RegulatoryMedical DevicesLeadership
About the role
- Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home.
- SUMMARY OF ROLE: The Product Complaint Manager is responsible for the end- to- end lifecycle of product feedback and quality issues.
- Escalate findings promptly. - Cross-Functional Reporting: Present findings to Executive Leadership and Quality Management Reviews, providing actionable insights that influence Engineering, Clinical and Manufacturing priorities.
Responsibilities
- Triage Oversight: Own the intake process for all incoming product feedback, distinguishing between general inquiries and events meeting the formal complaint definition per internal procedures.
- Investigation Oversight: Manage the end-to-end investigation process, ensuring technical teams identify failure modes and that documentation meets audit-ready standards. Maintain investigation completeness cycle time within SLA targets.
- Complaint Closure: Ensure each complaint is closed with complete investigation findings, root cause determination, risk assessment and appropriate regulatory assessment. Maintain closure cycle time within SLA targets.
- Trend Analysis: Perform Post-Market Surveillance (PMS) analysis to identify emerging risks or "signals" that were not previously identified in the Risk Management File. Escalate findings promptly.
- Own the intake process for all incoming product feedback, distinguishing between general inquiries and events meeting the formal complaint definition per internal procedures.
- Manage the end-to-end investigation process, ensuring technical teams identify failure modes and that documentation meets audit-ready standards.
- Maintain investigation completeness cycle time within SLA targets.
- Maintain closure cycle time within SLA targets.
- Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience-designed with both patients and clinicians in mind.
- MDR Assessment: Lead the assessment of adverse events for FDA reportability per internal procedures.
Compensation
- $135k-$160k
Benefits
- Ensure Medical Device Reports (MDRs) are submitted accurately and within statutory timelines.
Company info
- Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery.
- We are entering an exciting phase of growth as we move from development into early commercialization.
Visa & Work Authorization
- We are not able to sponsor individuals for employment visas for this job
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