1. Establish the product complaint handling process for Korea
2. Train and lead the key stakeholders involved in the product complaint handling process
3. Ensure that there is a system for adverse event report ability in the Korea including the distributors and consultant
4. Report all product complaints to product support group
5. Follow up closely on all the complaints ensuring each complaint is closed
6. Report adverse event to KFDA in accordance to KFDA guidance
7. Work closely with global product support group, regional regulatory support and Korea local RA operations to ensure that the process is running smoothly
8. Work closely with local RA to prepare artwork for Korean labeling(GARF/PAXPRO)
9. Work closely with local RA and local QA to ensure transfer of license process is in accordance to KFDA regulation and in compliance with KGIP
10. Assist local RA for regulatory affairs matter
경력 및 자격요건
1. 2-4 years experience in medical device QA function
2. Understanding KGIP and experience in working with in accordance to KFDA regulation
3. Exceptional command of English
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5045
cwlim@nterway.com
