Regulatory Affairs Manager

Updated: March 22, 2024 10:19 PM GMT

Full-time Job in Bekasi Regency, West Java

PT FAPON BIOINDUSTRIES INDONESIA

Bekasi Regency, West Java

Essential Function and Responsibility :

1. Identify the regulatory requirements for medical devices and in vitro diagnostic device in Indonesia, conduct regulatory research on the timing, process, and other relevant aspects of local product registration and import registration in Indonesia, and maintain good relationship and contact with the Indonesian Ministry of Health or CRO companies;

2. Keep track of changes in Indonesian regulations, take the lead in developing local registration plans for Indonesia, and assist to complete import registration plan for Indonesia;

3. Carry out local and import registration work in Indonesia according to the overall registration plan of the project;

4. Timely address relevant questions and needs related to Indonesian regulatory registration from internal and other departments;

5. Coordinate and communicate with relevant departments, and conduct regulatory training and implementation for relevant departments when necessary;

7. Undertake other... More Detail