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. _Proficient in Korean, facilitating the accurate interpretation and translation of Product Technical Complaints (PTCs) received from the respective countries._
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...
1. Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products,
biologics, and combination products, ensuring compliance with regulatory standards.
2. _Proficient in Korean, facilitating the accurate interpretation and translation of Product Technical Complaints (PTCs) received from the respective countries._
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...