Responsibilities:

• Stay Current with Regulatory and Industry.
  • Keep up-to-date with the latest trends, regulations, and changes in the precision medicine industry, particularly in relation to following regulations:特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法,Laboratory Development Test and Services (LDTS), ISO15189.
• Maintain and update LDTS database.
  • Working with cross functional teams to procure the latest documents.
  • Review and evaluate if any variation submission is required.
  • Support on managing laboratory technical personnel training records.
  • Support on maintaining product information.
• Support the preparation of LDTS submission dossiers within planned timelines.
• Support commercial team for
  • hospital listing and deficiency response.
  • commercial material review.
• Other regulatory actions and assistance.

Qualifications:

• University degree or equivalent combination of education, training and experience.
• 1 years experience in biotech or healthcare industry.
• Demonstrated attention to detail and organizational capabilities.
• Full working proficiency in English and Chinese.
• Proficiency in MSOffice applications, especially in Word, Excel, and PowerPoint.
• Great communication, collaboration, and problem-solving skills.
• Strong organizational skills and logic.
• Ability to learn, plan and work in a dynamic team environment.
• ‍Experience in preparing and reviewing regulatory submission documents is a plus.

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