Mô tả công việc
GENERAL DUTIES AND RESPONSIBILITIES
1. To be responsible for implementing and maintaining compliance with relevant regulations
and statutory requirements at all times, including chemicals, medical device, and other
applicable regulatory requirements, international standards, local regulations, codes of
practice, and legal requirements.
SPECIFIC DUTIES AND RESPONSIBILITIES
1. To achieve timely and efficient registration, declaration, licensing, and approval of Company
products (including chemicals, medical devices, and other regulated products), with regular
status reporting.
2. To facilitate product registration, licensing, import permit applications, and other regulatory
approval processes in accordance with applicable local regulations and quality system
requirements.
3. To ensure renewal of product registration, line extension, and any changes of registered
particulars are achieved in a timely manner with continual updates.
4. To collaborate with relevant divisions to ensure all imported and locally distributed products
remain compliant with applicable regulatory requirements throughout their lifecycle.
5. To maintain necessary record-keeping on regulatory related issues.
6. To liaise with regulatory authorities, auditors, certification bodies, and other external
stakeholders as and when required.
7. To provide supporting documents for all tender applications when necessary.
8. To advise, review, coordinate, and undertake all incidental matters to ensure the Company is
in compliance with the conditions of all licenses and relevant laws, regulations, notifications,
determinations, industry codes, guidelines and policy matters.
9. To ensure implementation of directives / notices from Government across the Company.
10. To support all licensing activities required by the Company's operations, to ensure that the
Company possess valid operating licenses / permits and to maintain ongoing compliance
with existing regulatory legislations.
11. To advise and update Management on government policies, affairs and requirements.
12. To perform any other work as and when required.
Yêu cầu
• Bachelor's degree or above in Biomedical Engineering, Medical Equipment Engineering, Biology,
Chemistry, Biotechnology, Pharmacy or other relevant disciplines.
• At least 2 years of experience in Regulatory Affairs, preferably in chemicals, medical devices, or
other regulated products.
• Sound knowledge of regulatory approval, product registration, licensing, and import permit
requirements for medical devices in Vietnam.
• Experience with import regulations for telecommunications equipment, electrical equipment,
laboratory animals, industrial chemicals, or other regulated products will be an advantage but
is not mandatory.
• Strong communication, coordination, and problem-solving skills, with the ability to work
independently and manage multiple regulatory projects simultaneously.
• Proficient in English, both written and spoken.
Quyền lợi
Nghỉ phép có lương
16 days of annual leave.
Máy tính xách tay
Company-provided laptop.
Khác
Working schedule: Monday to Friday (off on Saturdays and Sundays).
Meal allowance: VND 880,000 per month.
Salary negotiable based on qualifications.
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Thông tin chung
Nơi làm việc
- Xuan Hoa, Ho Chi Minh City, Vietnam
Cách thức ứng tuyển
Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút Ứng tuyển bên dưới:
Hạn nộp: 06/09/2026
