Opportunity Description
채용제목 RAQA Specialist 회사소개 미국계 의료기기 업무내용/자격요건 [담당직무]
Registration of New Products
Request to and search Registration Dossier for the required products
Review the information and documents from Company and related manufacturers.
Prepare the technical documents and compile applications.
Prepare the applications and arrangement related to product registration such as testing, sample preparation, etc.
Communicate with MFDS and related authorities and organization in process of product registration.
Follow up any additional and/or supplementary requests to complete product registration.
After completion of product registration, process post-registration activities defined by company.
KGMP Certification
Process KGMP certificates for new facilities and/or new product category through dossier or on-site inspection
Process periodic renewal of KGMP certificates through dossier or on-site inspection
Request and search the documents required.
Registration of New Products
Request to and search Registration Dossier for the required products
Review the information and documents from Company and related manufacturers.
Prepare the technical documents and compile applications.
Prepare the applications and arrangement related to product registration such as testing, sample preparation, etc.
Communicate with MFDS and related authorities and organization in process of product registration.
Follow up any additional and/or supplementary requests to complete product registration.
After completion of product registration, process post-registration activities defined by company.
KGMP Certification
Process KGMP certificates for new facilities and/or new product category through dossier or on-site inspection
Process periodic renewal of KGMP certificates through dossier or on-site inspection
Request and search the documents required.