Mgr., Product Complaints (Hybrid)

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. 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. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Essential Functions:

• 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 noncompliant 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.

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.
• Experience providing oversight of externally performed medical device investigations (e.g., CMOs or device manufacturers) preferred.
• Handson experience with complaint systems compliant with 21 CFR Part 820 (QMSR), ISO 13485, and EU MDR.
• Prior involvement in medical device recalls or field actions preferred.
• Medical Device (auto-injector) and/or combination product experience preferred but not required.
• Strong knowledge of:
  • FDA Medical Device Reporting (21 CFR Part 803)
  • EU MDR vigilance and complaint handling requirements
  • ISO 14971 risk management principles
  • IEC 623661 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.
• Ability to work a hybrid schedule (a minimum of 3 designated days onsite)

Eisai Salary Transparency Language:

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 is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, 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 status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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