Ra Manager, Bangkok

Thailand, Thailand, Bangkok
เผยแพร่แล้ว 2025-07-01
หมดอายุ 2025-08-01
ID #2959019385
Free
Ra Manager, Bangkok
Thailand, Thailand, Bangkok,
เผยแพร่แล้ว July 1, 2025

คำอธิบาย

Our client is a global medical device company who provides consumable products to hospitals.

Job Description

  • Supporting any Quality Regulatory Compliance related special projects that are assigned by company policy as well as by the change of Thai FDA regulation and requirement.
  • Preparing, registering, and gathering documents related to the registration process to get both new and renewed import licenses e.g. Certificate of Free Sale/ Certificate of Goods/ Free Sale Certificate, ISO/ any other applicable standard certificate, product catalog/ brochure, Instruction for use/ Notice, and declaration letter(if needed).
  • Overseeing the changes and/ or new legislation, requirements, applicable standard, and/ or requirement that lead to an impact on the registration process and Quality Management System.
  • Gathering, filing, and maintaining all data/information regarding FSCA, AE, Customer Complaints, and any other related QA/RA issues.
  • Acting as Document Control Center to handle all quality and regulatory documents related to applicable standards for Quality Management System.
  • Qualifications

  • Bachelor’s Degree in Science, Medical, or related fields.
  • 4-5 years of experience in the Medical Device products registration process or related field.
  • Knowledge of the registration process and/ or DCC for any applicable QMS (ISO).
  • Good command of English & Thai both written and spoken.
  • Good computer literacy (MS Office: Word, Excel, Access, and Power Point).
  • รายละเอียดงาน

    ประเภทงาน: เต็มเวลา
    ประเภทสัญญา: ถาวร
    ประเภทเงินเดือน: รายเดือน
    อาชีพ: Ra manager

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