Intern - Regulatory Affairs

7 hours ago

Taipei Taipei City, Taiwan B. Braun Group Full time $30,000 - $40,000 per year

Job Description

  • Administrative and technical documents preparation, data document sorting and archiving, administrative work support.
  • Preparation of License renewal, QSD submissions, Administrative amendments for licenses.
  • Update Chinese IFU to current English IFU by performing gap analysis, translation of contents, and editing Chinese IFU formats per current regulation.
  • Data mapping support to exported data from UDI, SAP, LIS, ALS systems.
  • Update files in license and QSD databases.
  • Filing of Regulation and training presentations.
  • Provide support to RA projects/initiatives.
  • Assist in mastering the progress of MP&A projects.
  • Communications with cross departments within the company and TFDA officers.
  • Ensure all assigned tasks fulfillment within timeline.
  • The job function listed is not exclusive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Qualifications And Requirements

  • Education background in medical or medical device expertise, such as medical science, medicine, nursing or biomedical engineering related field

Personal and Skills

  • Good reading and writing skills in Chinese/English
  • Basic data editing and document management ability
  • Good knowledge of MS Word, EXCEL & PowerPoint
  • English IFU reading and translation ability
  • Having relevant experiences in pharma or medical device registration, regulation, etc. are preferred
  • Good concept of human anatomy and physiology, and common disease terms.
  • Careful, detail oriented, Patient
  • Proactive, Can do Attitude
  • Accurate, Independent, Helpful & supportive

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