Regulatory Affairs Intern

Introduction

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, Korea, USA and Germany. We are looking for a Talented Regulatory Affairs Intern who is fluent in English and be able to understand to medical device regulations 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.
• Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
• Investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
• Other duties as assigned.

Requirements

• Can work at least 24 hours per week for a duration of 4 months to 6 months.
• Fresh graduates for senior students in related majors, such as biomedical engineering, biotechnology, pharmaceutical.
• Fluent in English is a must, in other languages will be an advantage. Candidates who can speak Chinese will be a big plus.
• Ability to manage multiple projects, set priorities to meet deadlines.
• Keeping attention to details.
• Strong interpersonal skills, in written and oral.
• Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.
• Only recruiting female candidates.

Benefits

• Allowance: The hourly rate ranges from VND 40,000 to 50,000, depending on ability.
• Confirmation of completing the internship.
• Have chances to become a full-time employee.
• Professional, dynamic working environment.