Regulatory & Quality Specialist
Thermo Fisher Scientific
South Korea
20 일 전

Responsibilities

  • Registration of products per regulations and communication with government officials
  • Submissions to support reimbursement process with NECA and HIRA
  • 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

  • A bachelor or higher degree in Biology, Microbiology, Molecular Biology, Medical Science, etc.
  • Work 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
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