Job Description

Our client is a leading medical device manufacturer in Thailand.

Key Responsibilities

  • Assisting in regulatory issues including product registration submission, variation application, and advertising company licenses following Thai Regulations.
  • Interacting and coordinating with regulatory agencies to expedite the approval of registrations.
  • Assisting in reviewing regulatory documents and materials such as package inserts, labels, and other packages.
  • Supporting other regulatory issues such as COA translation, goods release, SOPs, etc.
  • Maintaining regulatory database and reporting regularly.
  • Supporting Regulatory Affairs Leader and regulatory team in preparing purchase requests, and expenditures, supporting internal communication work, meetings, sending sample testing, etc.
  • Preparing documents for batch release application, sample license, raw material permission, and variation packaging per timeline, to submit at Thai...
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