Eisai
Mgr., Product Complaints (Hybrid)
North Carolina, Raleigh · Senior
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
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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.
Responsibilities
- 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.
- Author, own, and maintain SOPs related to Complaint Handling and Oversight
- Drive continuous improvement initiatives related to complaint handling effectiveness, investigation quality, and compliance.
Requirements
- 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:
Skills
- 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.
- Please click on the following link for more information:
- Right To Work
- E-Verify Participation
Compensation
- Eisai Salary Transparency Language:
Benefits
- 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).
Visa & Work Authorization
- 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.