Careers at ThermoFisher Scientific

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Job ID :
Location :
South Korea - Seoul
Job Description

Position Overview

The RA QA specialist will be required to carry-out the following job responsibilities to ensure compliance with MFDS and other government authorities


  • Registration of products per regulations and communication with government officials
  • Submissions to support reimbursement process of nHTA (new Health Technology Assessment) and CPT code registration to enter the medical market
  • Updates & maintenance of records on legislation, regulations, guidelines and regulatory files
  • Product review to classify the medical devices and non-medical devices
  • Product control to meet Korea regulations of each product classification
  • Train Korean organization on MFDS regulations and quality requirements
  • Label manage to eliminate risk associated with local labeling requirement
  • Assist in the preparation of post market reports and submissions such as recall, adverse event report and complaint
  • Prepare site for random audits of MFDS and other government authorities
  • Support KGMP inspections of overseas manufacturers

Requirements/Education :

  • A bachelor or higher degree in Biology, Biotechnology, Molecular Biology, Medical Science, etc.
  • 3+ working experience as the RA of medical device field is preferred
  • Able to work, under pressure and flexible working hours based on business requirements
  • Independent, proactive and able to work in a matrix environment
  • Good analysis skill on data trending and data segment
  • Good root cause analysis and problem solving skill

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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