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[의료기기 기업] Product registration of newly implantable products
외국계 치과재료 제조 유통사   2022-10-05
면접후 협의   4년제 대졸이상
서울송파   진행

1. 담당 업무

  -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.       


-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 labelling when registering product

-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


2. 자격 요건

- 유관 경력 2년 이상

Experience in registering an implantable medical devices (Class3~4)

Fluent in English

3. 기타

- 산휴대체 <계약직> 임


원경림   이사
02-6925-3341/010-2751-5485   won@bbp.co.kr