Manager, Product Complaint

Responsibilities

• (including, but not limited to) :
• Ensure all product complaints are received, reviewed, evaluated, and investigated in accordance with applicable procedures to determine reportability to FDA and international regulatory authorities.
• Manage and perform complaint intake, triage, investigation, and closure, documenting all activities accurately and contemporaneously within the electronic Quality Events system.
• Communicate directly with complainants (e.g., patients, healthcare providers, distributors) to obtain complete and accurate information necessary to support product complaint investigations.
• Maintain and execute complaint handling processes and procedures to ensure compliance with internal quality system requirements and applicable global regulations and standards.
• Monitor and ensure ongoing compliance with company policies and procedures, as well as FDA, EU GMP, ICH, and other applicable regulatory requirements.
• Contribute to the development, revision, and continuous improvement of SOPs and work instructions related to complaint handling and vigilance activities.
• Initiate, document, and implement Corrective and Preventive Actions (CAPAs) when complaint trends, investigations, or risk assessments warrant action, in accordance with established procedures.
• Coordinate and actively participate in the escalation of product complaints, including cross ‑ functional collaboration with Quality, Manufacturing, Regulatory Affairs, Medical Safety, and Technical teams.
• Serve as a point of contact for internal and external stakeholders, responding to requests, explaining complaint handling processes, and supporting cross ‑ functional alignment.
• Interact with internal, domestic, and international auditors and inspectors, providing documentation, explanations, and subject matter expertise related to complaint handling processes.
• Ensure appropriate training is delivered to relevant employees and vendors; develop and deliver product complaint training and periodically assess and update training materials to ensure effectiveness.
• Perform monthly reconciliation of product complaints and adverse event/safety information with Global Medical Safety / Drug Safety to ensure accurate and complete regulatory reporting.