Intern - Regulatory Affairs

Job Description

1. Administrative and technical documents preparation, data document sorting and archiving, administrative work support.
2. Preparation of License renewal, QSD submissions, Administrative amendments for licenses.
3. Update Chinese IFU to current English IFU by performing gap analysis, translation of contents, and editing Chinese IFU formats per current regulation.
4. Data mapping support to exported data from UDI, SAP, LIS, ALS systems.
5. Update files in license and QSD databases.
6. Filing of Regulation and training presentations.
7. Provide support to RA projects/initiatives.
8. Assist in mastering the progress of MP&A projects.
9. Communications with cross departments within the company and TFDA officers.
10. 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