1. Lead the investigation of complaints that include all complex scenarios:
o Evaluate event to determine if it qualifies as a complaint
o Manage customer relationship and expectations during course of complaint investigation and resolution process
o Assess complaint information provided and translate before submit to EU CHU
o Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
o Prepare and submit MDR reports to NMPA, including China MDR and oversea MDR
o Translate and submit final customer correspondence
2. Analyze complaint and MDR data and report out by using monthly dashboard and quarterly PMS review meeting; Identify problems and escalate for any abnormal trending or hot issues. Lead and plan agenda for and run meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint.
3. Develop China PRAR plan and work with global stakeholder to prepare PRAR report with in accordance to regulatory requirements, trial safety processes, and EW procedures.
Complete PMS reports for Hongkong as per local regulatory requirements.
4. New Initiatives and projects
5. Other incidental duties
Education and Experience: