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Global Regulatory Affairs Specialist (no country restriction)

Job description

Responsibilities include, but are not limited to:

✮ 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 a 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.

✮  No restriction on Nationality.

  

Location

Taipei, Taiwan.

Possible to be assigned/rotated between other ASEAN countries.

  

Contact window

Please send resume and cover letter to Ms. Irene Lu ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ).

 

Qualtech Internship Program 2019

Qualtech and Beijing Niuchuang Tech is looking for students with a diverse range of profiles and experiences to assist us in ongoing and upcoming projects related to medical device registrations in the countries we service for. Beijing Niuchuang Tech is the branch of Qualtech in China. Qualtech is a medical device regulatory consulting company and a clinical trial organization (CRO) with branch offices in East Asia and Southeast Asia.

Our commitment is to leverage the talent of a diverse workforce to create great opportunities for our clients, our people and our business.

  

Location: Taipei, Beijing, Philippine

  

Time Commitment:

Flexible schedule at maximum 20 hours per week during the semester.

  

What you’ll be doing…

  • ✮   Requesting customers for necessary documentation for regulatory submissions, maintain and manage those documents.

   Monitors and maintains projects with internal departments and provide updates to customers.

   Gathering information regarding the requirements and relative procedures for medical device registration within the country.

   Searching and translating regulatory information published in the local authorities.

   Other tasks assigned by superior.

  

We’d love to meet someone with…

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

  Candidates who speak Chinese will be a big plus. English is preferable.

   Ability to manage multiple projects and set priorities to meet deadlines.

   Keen attention to details.

   Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.

 

Candidates who are interested in the position shall send their CV to Eve Peng ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it )

 
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