Position Title: Global Regulatory Affairs Specialist
Job description
- 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.
Requirements
- 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 Chinese will be a big plus.
- Ability to manage multiple projects, set priorities to meet deadlines.
- Keen attention to details.
- Strong interpersonal skills, in written and oral.
- Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.
Location: Dien Bien Phu, Binh Thanh, Ho Chi Minh city.
Working time: 8:00-17:00, Monday-Friday
Benefit
- Salary: 9 – 13m VND
- Bonus 13th salary and Performance bonus
- Professional, dynamic working environment
- Domestic and overseas training opportunities.
- Insurance & Paid-leaves as required by Labor Law
Deadline for application: December 20, 2021
Contact window: Please send resume and cover letter to Ms. Vivian (vivian@qualtechs.com).