Regulatory Affairs Specialist — Medical Devices (AKD/NIE)

Dwigraha Medical; Desa Ciranjeng; On-site; IDR 66,960,000 - 111,600,000; Full time

Benefits offered by this job

Medical

Miscellaneous allowance

Loans

Parking

Transportasi

BPJS Ketenagakerjaan

BPJS Kesehatan

Job summary

PT Dwiasri Graha in Indonesia seeks a Regulatory Officer with 1 year of regulatory affairs experience in medical devices. You will manage registrations, renewals, and changes to distribution permits, prepare DIP documents, and ensure compliance across products.

The role requires meticulous document management, strong coordination with internal teams, and the ability to adapt to regulatory changes. This is a full-time, on-site position with benefits including BPJS-related programs.

Qualifications

• Minimum D3/S1 in Pharmacy, Health, Biomedics, or related field.
• 1 year experience in Regulatory Affairs for medical devices.
• Understanding of AKD/NIE, DIP, and CDAKB processes.
• Meticulous, organized, and able to handle large volumes of documents.

Responsibilities

• Manage registration, renewal, and changes to medical device distribution permits (AKD/NIE).
• Prepare and ensure completeness of registration documents and Product Information Documents (DIP).
• Ensure all distributed products have valid distribution permits and regulatory documents.
• Monitor changes in medical device regulations and ensure compliance with applicable provisions.
• Coordinate with principal, QA, PJT, and related teams in fulfilling regulatory documents.
• Support the fulfillment and maintenance of CDAKB and implementation of regulatory audits.
• Manage regulatory documentation and reporting through applicable systems.

Skills

Regulatory affairs

Documentation

Coordination

Communication

Education

D3/S1 in Pharmacy, Health, Biomedics, or related field

Job description

PT Dwiasri Graha in Indonesia seeks a Regulatory Officer with 1 year of regulatory affairs experience in medical devices. You will manage registrations, renewals, and changes to distribution permits, prepare DIP documents, and ensure compliance across products.

The role requires meticulous document management, strong coordination with internal teams, and the ability to adapt to regulatory changes. This is a full-time, on-site position with benefits including BPJS-related programs.