Qualtech Consulting Corporation Recruitment

Position Title: Regulatory Affairs Specialist
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 Regulatory Affairs Specialist 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.
• Support the tasks for Sales team
• Other duties as assigned.
Requirements
• Major in related majors, such as biomedical engineering, biotechnology, medicinal chemistry.
• Fluent in English is a must, in other language will be an advantage. Candidates who can speak
Chinese will be a big plus.
• At least one-year experience in RA field
• 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.
• Gender: Female
• Prioritize Quang Ngai residents
Benefits
• Salary: negotiated
• Social Insurance, Medical Insurance, Unemployment Insurance benefits.
• 13th month pay (shall consecutively work for 1 year).
• Annual leave with pay.
• Professional, dynamic working environment.
• Have a chance for oversea training
Location: new office in Quang Ngai city
Working time: 8:00-17:00, Monday-Friday
Deadline for application: Aug 20th, 2026
Contact window: Please send resume and cover letter to Ms. Vivian (vivian@qualtechs.com).