Mgr., Product Complaints (Hybrid)

Eisai US•Raleigh, NC

2d•$104,900 - $137,700•Hybrid

About The Position

The Manager, Product Complaints is responsible for the oversight, governance, and continuous improvement of Eisai’s medical device complaint handling process. This role ensures that medical device complaints are consistently captured, appropriately triaged, thoroughly reviewed, and closed in compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR, and Eisai quality system requirements. The role serves as the single point of entry for all Raleigh site commercial product complaints to ensure data quality and consistency; however, the position only triages and fully manages medical device complaints. This role is accountable for reviewing, challenging, accepting, and approving investigations from the device manufacturer on behalf of Eisai. This role partners closely with medical information by providing high-quality medical device complaint data, accepted investigation outcomes, and trend analyses to support vigilance and signal management activities as part of the Post-Market Surveillance program (PMS).

Requirements

Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmacy, or a related technical field.
5+ years of experience in medical device complaint handling, post market quality, or related quality system roles, required.
Hands‑on experience with complaint systems compliant with 21 CFR Part 820 (QMSR), ISO 13485, and EU MDR.
Strong knowledge of: FDA Medical Device Reporting (21 CFR Part 803)
EU MDR vigilance and complaint handling requirements
ISO 14971 risk management principles
IEC 62366‑1 usability engineering
Strong cross functional collaboration and stakeholder influence skills.
Excellent organizational, time management, and technical writing capabilities.
Values aligned with Eisai’s mission and patient first culture, including integrity, professionalism, quality, and teamwork.

Nice To Haves

Experience providing oversight of externally performed medical device investigations (e.g., CMOs or device manufacturers) preferred.
Prior involvement in medical device recalls or field actions preferred.
Medical Device (auto-injector) and/or combination product experience preferred but not required.

Responsibilities

Serve as the single point of entry for all Raleigh site product complaints, ensuring timely, accurate, and complete complaint documentation while following established Eisai procedures for routing all complaints.
Triage and classify medical device complaints, including confirmation of device involvement, user error considerations, and potential quality or safety impact.
Own and oversee the end-to-end lifecycle of medical device complaints, including intake, triage, investigation oversight, escalation, documentation, and closure.
Apply human factors and usability engineering principles to assess whether events are attributable to user error, use related risk, foreseeable misuse, or product quality/design issues.
Manage complaint sample handling (shipping, tracking) to external sites for investigation.
Review investigation strategies, failure analysis methodologies, root cause determinations, and supporting evidence to ensure investigation adequacy, scientific rigor, and regulatory compliance.
Escalate inadequate, delayed, or non‑compliant investigations through Quality governance and supplier oversight mechanisms.
Establish and monitor medical device complaint metrics, dashboards, and trend analyses (e.g., failure mode, component, lot/batch, time to event).
Ensure complaint data effectively informs CAPA, risk management, and product improvement initiatives.
Author, own, and maintain SOPs related to Complaint Handling and Oversight
Drive continuous improvement initiatives related to complaint handling effectiveness, investigation quality, and compliance.