Regulatory Officer

Dwigraha Medical; Jakarta Timur; On-site; IDR 89,280,000 - 133,920,000; Full time

Benefits offered by this job

Medical allowance

Miscellaneous allowance

Parking

Transportasi

BPJS Ketenagakerjaan

BPJS Kesehatan

Loans

Job summary

PT Dwiasri Graha is seeking a Regulatory Officer to oversee registration, renewal, and changes for medical device distributions. You will prepare regulatory documents and ensure all products have valid permits, while tracking regulatory updates and coordinating with internal teams and principals.

The role requires a background in regulatory affairs for medical devices, with strong document management, organization, and communication skills.

Qualifications

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

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.

Skills

Meticulous

Organized

Communication skills

Coordination

Education

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

Job description

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

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