Manages a team of postmarket surveillance technicians responsible for daily administration of customer complaints , vigilance reporting, and investigation of active devices across multiple companies and divisions.
Supports maintenance of the compliance of the post-market surveillance system to the requirements of 21 CFR 820, 21 CFR 211, 21 CFR 803, ISO 13485, Regulation EU2017/45, and other applicable regulations and laws concerning medical products
Ensures established timelines for complaint handling activities and associated tasks are met and that all work is of high quality
Supports Associate Director, Postmarket Surveillance and Manager, Customer Complaint Advocacy in managing escalating quality concerns and responding to the needs of the sales team and customers
Ensures budgetary requirements are fulfilled and identifies and implements opportunities for efficiency improvement in complaint handling activities