Chuyên viên Pháp chế (Regulatory Affairs Executive)

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 công việc

• 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.