LEGAL STAFF

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

This role involves managing legal and regulatory affairs for the distribution of orthopedic medical devices in Indonesia. The position requires expertise in medical device licensing, regulatory compliance, and coordination with government agencies and international principals.

Key responsibilities

Manage registration, renewal, and updates of medical device distribution permits (AKL)

Ensure completeness, validity, and compliance of product registration documents with applicable regulations

Manage compliance with Good Distribution Practices for Medical Devices (CDAKB) and ensure proper implementation

Administer product listing, updates, and data maintenance on the government e-Katalog system

Ensure product data on e-Katalog aligns with distribution permits, legal documents, specifications, and approved product information

Monitor validity periods of AKL permits, CDAKB certificates, and company legal documents

Coordinate with principals and relevant government agencies in licensing and product requirement fulfillment processes

Prepare and update legal documents, SOPs, and archives related to medical device licensing and distribution

Ensure distribution activities and company legal administration comply with applicable regulations

About you

Minimum S1 degree in Law, preferably with experience in legal affairs and medical device licensing

Minimum 1–2 years of experience in legal, regulatory affairs, or licensing, particularly in medical device distributor companies

Understanding of Indonesian medical device licensing and distribution regulations

Experience managing registration, renewal, and updates of medical device distribution permits (AKL) through the Indonesian Ministry of Health system

Understanding of administrative requirements and technical documentation for medical device distribution permit registration, including coordination with principals or manufacturers

Understanding of Good Distribution Practices for Medical Devices (CDAKB) requirements and implementation, including document management, audit preparation, and follow-up on evaluation results

Understanding of administrative processes and product management on the government e-Katalog system, including preparation of product legal documentation, product data updates, and fulfillment of administrative requirements for product display

Understanding of business licensing through OSS-RBA, NIB, standard certificates, and other licensing related to medical device distribution activities

Ability to prepare, review, and manage company legal documents, cooperation agreements, power of attorney, and supporting documents

Ability to monitor validity of AKL distribution permits, CDAKB certificates, and other legal documents and ensure timely updates

Ability to coordinate with the Ministry of Health, relevant government agencies, principals, and internal company departments

Proficiency in Microsoft Office, particularly Word and Excel, and ability to manage databases and medical device licensing document filing

Attention to detail, responsibility, communication skills, strong analytical ability, and ability to work within deadlines

PT. SYAHARANI is a private company that operates in the field of medical devices, which was founded in 2006. This company was established to provide medical devices to hospitals so that the supporting tools needed to perform surgical operations are of the highest quality.

Besides that, PT. SYAHARANI distributes various types of medical devices with the ORTHINDO brand and others that have good standard and quality and at very competitive prices. There are about 108 types of products that we have successfully distributed over the past 9 (nine) years throughout Indonesia.