Global Regulatory Affairs Specialist

• Oversight of regulatory submissions for assigned projects/countries, which may include completion of submissions or notifications, as required.
• Independently interacts and builds partnerships with competent authorities.
• Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
• Providing advice and support to the project team for regulatory or technical aspects of the projects.
• Investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
• Other duties as assigned.

Preferably Bachelor students or above. Knowledge in medical-related field will be a plus.

Fluent in English is a must, in other language will be an advantage. Candidates who can speak a Chinese will be a big plus.