Regulatory Officer

Dwigraha Medical; Desa Ciranjeng; Presencial; IDR 66.960.000 - 111.600.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical

Miscellaneous allowance

Loans

Parking

Transportasi

BPJS Ketenagakerjaan

BPJS Kesehatan

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory affairs

Documentation

Coordination

Communication

Educación

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

Descripción del empleo

PT Dwiasri Graha, a company operating in the distribution of medical devices and BMHP, is opening an opportunity for those with experience in the regulatory field of medical devices to join as a Regulatory Officer.

Key responsibilities

Manage the process of 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 company 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

About you

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

Have 1 year experience in Regulatory Affairs for medical devices, particularly in distribution, is an added value

Understanding of medical device registration processes, AKD/NIE, DIP, and CDAKB

Meticulous, organized, and able to manage large volumes of documents

Good communication and coordination skills with internal teams and principal

Able to work independently and as part of a team

Perks and benefits Medical Miscellaneous allowance Loans Parking Transportasi, BPJS Ketenagakerjaan, BPJS Kesehatan