Chuyên viên Pháp chế (Regulatory Affairs Executive)
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 ứng viên
- 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/Phúc lợi
- 16 days of annual leave.
- Company-provided laptop.
- Working schedule: Monday to Friday (off on Saturdays and Sundays).
- Meal allowance: VND 880,000 per month.
- Salary negotiable based on qualifications.
Địa điểm làm việc
- P. Xuân Hòa, Thành phố Hồ Chí Minh
| Quy mô: | Chưa cập nhật |
| Lĩnh vực: | Kinh doanh |
| Địa chỉ: | Phòng E31, số 40 đường Bà Huyện Thanh Quan, Phường Xuân Hòa, TP Hồ Chí Minh |
| Tên công ty: | Công ty TNHH Một Thành Viên Khoa Học Công Nghệ Tích Hợp Vạn Nam |
| Quy mô: | Chưa cập nhật |
| Lĩnh vực: | Kinh doanh |
| Địa chỉ: | Phòng E31, số 40 đường Bà Huyện Thanh Quan, Phường Xuân Hòa, TP Hồ Chí Minh |
| Ngày đăng tuyển: | 08/08/2026 |
| Cấp bậc: | Chuyên viên |
| Học vấn: | Đại học |
| Số lượng tuyển: | 1 |
| Độ tuổi: | Không yêu cầu |
| Giới tính: | Không yêu cầu |
| Hình thức làm việc: | Toàn thời gian |
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