Regulatory Affairs

PT. Sinocare Healthcare Indonesia; Jakarta Utara; On-site; IDR 600,000,000 - 1,000,000,000; Full time

Job summary

PT. Sinocare Healthcare Indonesia seeks an experienced Regulatory Affairs professional to lead end-to-end product registrations and licensing in Indonesia.

You will coordinate with the Ministry of Health and other authorities, prepare technical files, and monitor regulatory changes affecting the business. The role requires a strong track record in medical device regulatory affairs, formal education in a relevant field, and excellent English communication.

Qualifications

• Bachelor's degree in a relevant 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.

Responsibilities

• 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.

Skills

Regulatory affairs expertise

English communication

Education

Bachelor's degree in Pharmacy, Biomedical Engineering, Public Health, Biology, Medical Laboratory Technology

Job description

· 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.