Skill diminta
CommunicationEnglishMandarin
Deskripsi
Job Descriptions
- Manage end-to-end product registration (AKL, AKD, renewal, variation, amendment).
- Maintain IDAK, CDAKB, OSS/NIB and other company licenses.
- Coordinate with the Ministry of Health and other government authorities.
- Prepare and maintain regulatory documentation and technical files.
- Support product launch, importation, and licensing activities.
- Monitor regulatory changes and advise management on business impact.
- Support regulatory inspections and internal/external audits.
- Coordinate with HQ and cross-functional departments.
- Maintain regulatory databases and submit monthly status reports.
Requirements
- Bachelor's degree in Pharmacy, Biomedical Engineering, Public Health, Biology, Medical Laboratory
- Technology, or related field.
- Minimum 10 years of experience in Medical Device Regulatory Affairs.
- Strong knowledge of AKL, AKD, IDAK, CDAKB and Ministry of Health regulations.
- Experience handling government inspections and product registration.
- Good communication skills in English; Mandarin is an advantage.
- Highly organized, detail-oriented and able to work independently.