Legal Staff

About the role

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