Job Description
Core responsibilities:
1. Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products,
biologics, and combination products, ensuring compliance with regulatory standards.
2.
3. Collaborate with internal/external stakeholders via Cross functional teams (Manufacturing
sites, Customer Service, Medical Information, Pharmacovigilance, Regulatory, Legal, Field
Alert Reporting, risk management departments, etc.) (as applicable) for complaint
management.
4. Conduct management of complaints into the proper database (as applicable) and perform
assessment, ensuring timely processing as per defined scope. Focus on operational tasks
within the complaint handling process.
5. Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan.
6. Participate in ad-hoc meetings for product-specific complaint issues and provide...
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