Product Complaint Supervisor

Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Supervising a small team of product analysts to meet the objectives established by the Department Manager. Monitoring daily operations and work-in-progress (WIP) to ensure efficiency and adherence to quality standards and regulatory requirements. Supporting the professional development of individual contributors, helping them grow their skills and advance their careers. Coordinating efforts with corporate partners and liaising with multiple geographical locations to align strategies and achieve common goals. Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations. Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. Establish and approve regulatory reportability decisions using event investigation and regulatory decision models. Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations. Write and approve Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities. Degree in Biology, Health Sciences, Biotechnology or Engineering Self-motivated, goal-drive, and results-oriented team player Strong written and verbal communications skills Direct or indirect leadership experience Prior complaint handling experience Excellent time management and organizational abilities Experience with SAS, PowerBI, or TrackWise applications Experience with Electrophysiology products