SUMMARY OF POSITION New product registration & Maintenance of existing product license
Management of internal/external KGMP audit/inspections as company representative.
Document control: Device Master File, SOPs and Quality manuals
Quality oversight of the storage and release testing of products
Focus person for any quality issues : Product complaints etc.
DUTIES & RESPONSIBILITIES
Product registration:
Prepare the document and manage the process for new product registration & maintenance/update of existing product licenses with MFDS
Communicate with manufacturing sites to get the required documents and product dossiers
Develop local language labeling when registering products
Verify the Korean text file for advertisements of the products developed by marketing team
Quality Assurance:
Prepare for the successful KGMP on-site audit by MFDS/NB
Prepare for the successful KGMP renewal by MFDS/NB in every three years
Communicate with manufacturing sites to get the required documents and dossiers on time
Adverse events reporting
Job requirement
- Experience in registering an implantable medical devices (Class 3~4)
- Fluent in English
- No reason for disqualification for oversea travels
**산휴 대체 근무 기간: 1년 3개월 (내부 상황에 따라 연장 혹은 단축 될 수 있습니다.)
근무지 : 서울시 송파구 문정동 | 
