Regulatory Affairs & Licensing Specialist – Medical Devices

PT Syaharani; Surabaya ꦱꦸꦫꦧꦪ; On-site; IDR 150,000,000 - 270,000,000; Full time

Job summary

PT. SYAHARANI, a medical devices distributor founded in 2006, seeks a Regulatory Affairs professional to manage Indonesian licensing, registration, and compliance for orthopedic devices.

The role focuses on AKL permits, CDAKB compliance, and coordination with the Ministry of Health and other agencies. You will prepare legal documents, maintain product data in the e-Katalog system, and ensure timely updates across OSS-RBA and other licenses.

Qualifications

• Minimum S1 degree in Law with experience in legal affairs and medical device licensing.
• Minimum 1–2 years in legal, regulatory affairs, or licensing, preferably in medical device distributors.
• Understanding Indonesian medical device licensing and distribution regulations.
• Experience managing AKL registration, renewal, and updates through the Ministry of Health system.
• Knowledge of CDAKB and Good Distribution Practices for Medical Devices.

Responsibilities

• Manage registration, renewal, and updates of AKL permits.
• Ensure completeness and compliance of product registration documents.
• Ensure CDAKB compliance and proper implementation.
• Administer product listing and data maintenance on the government e-Katalog system.
• Align product data on e-Katalog with permits and approved product information.
• Monitor validity periods of AKL permits, CDAKB certificates, and legal documents.
• Coordinate with principals and government agencies on licensing processes.
• Prepare and update legal documents, SOPs, and archives related to medical device licensing and distribution.
• Ensure distribution activities comply with regulations.

Skills

Regulatory affairs

Legal compliance

Documentation management

Coordinate with authorities

Attention to detail

Communication skills

Data management

Education

S1 in Law

Tools

Microsoft Word

Microsoft Excel

e-Katalog system

Job description

PT. SYAHARANI, a medical devices distributor founded in 2006, seeks a Regulatory Affairs professional to manage Indonesian licensing, registration, and compliance for orthopedic devices.

The role focuses on AKL permits, CDAKB compliance, and coordination with the Ministry of Health and other agencies. You will prepare legal documents, maintain product data in the e-Katalog system, and ensure timely updates across OSS-RBA and other licenses.