Eisai

Mgr., Product Complaints (Hybrid)

North Carolina, Raleigh

Sponsorship not specified$105k-$138kDetected 28 days ago

FDA RegulatoryMedical DevicesResearchCollaborationTime ManagementWritingRegulatory Affairs

About the role

We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development.
Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease.
If this is your profile, we want to hear from you.

Manage complaint sample handling (shipping, tracking) to external sites for investigation.
Author, own, and maintain SOPs related to Complaint Handling and Oversight
Drive continuous improvement initiatives related to complaint handling effectiveness, investigation quality, and compliance.
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.

Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmacy, or a related technical field.
Hands‑on experience with complaint systems compliant with 21 CFR Part 820 (QMSR), ISO 13485, and EU MDR.
Strong knowledge of:

Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs.
For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai Inc. participates in E-Verify.

The annual base salary range for the Mgr., Product Complaints (Hybrid) is from:$104,900-$137,700

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.
The Manager, Product Complaints is responsible for the oversight, governance, and continuous improvement of Eisai's medical device complaint handling process.
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.
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.
Establish and monitor medical device complaint metrics, dashboards, and trend analyses (e.g., failure mode, component, lot/batch, time to event).

As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.

re, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran statu

This listing is sourced directly from Eisai's careers page and normalized into a canonical job model.