Home > Open Position

Open Position

Open Position

진단기기 기업 RA Manager 부장님 본부장님 채용합니다.

  • 2021-08-25 08:55:00
  • 1.223.120.93

           Major Responsibilities:

           1.  Lead on WHO Prequalification Program

           2.  Lead on IVDR Project/CE marking/CE certification by Notified Body

           3.  Manage on overseas registration (APAC, LATAM, RCIS & Africa)

           4.  Vigilance/Medical device reporting

           5.  Managing overall Regulatory works in MFDS

           6.  Technical file management     

           7.  Tender business support _ Technical/Tender application

           8.  Lead on Rebranding project

           9.  Manage on updating GRID system

           10. Maintain up-to-date International Standard/Regulation

           Basic Qualifications

           - GMP Quality Contol/Assurance training

           - ISO 13485 training

           - Global Regulations/Standard

           - WHO PQ program _ 10 PQed products

           - CE IVDD/IVDR certification

           - Get the Product License in global

           - Manage RA and Operation consultant  

게시글 공유 URL복사