Global Regulatory Affairs Specialist

Qualtech is an Asia Medical Device Consulting and Clinical Trial (CRO) Company with branch offices in China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Vietnam, Thailand, USA and Germany. We are looking for a Regulatory Affairs Specialist who is fluent in English and Chinese (preferable) to help us take care project management related to medical device registrations in the countries we service for. 

Qualtech is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people.

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.

- 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. 

- Bonus 13th salary and Performance bonus

- Insurance & Paid-leaves as required by Labor Law

- Professional, dynamic working environment

- Domestic and overseas training opportunities.