Regulatory Affairs Officer — Medical Devices (MoH)

PT CONKOTE MEDICAL INDONESIA; Jakarta Pusat; On-site; IDR 180,000,000 - 240,000,000; Full time

Benefits offered by this job

Attractive salary and monthly perf.–in

Religious Holiday Allowance (THR)

Annual leave entitlement

Collaborative and supportive team

Work-life balance: Monday to Friday

Job summary

PT CONKOTE MEDICAL INDONESIA is seeking an experienced Regulatory Affairs Officer to ensure compliance with Indonesian health regulations and lead medical device submissions to the MoH. The role emphasizes technical leadership and cross-functional collaboration in a full-time capacity at our Central Jakarta operations.

Key responsibilities include developing SOPs for registration, managing OSS, IDAK, CDAKB processes, and coordinating LKPP/Inaproc activities.

Qualifications

• Bachelor’s Degree or Professional Pharmacist qualification.
• Valid STRA or STRTTK.
• CDAKB Training Certificate for PJT (issued by the Ministry of Health).
• Minimum 2 years of experience as PJT in the medical device industry.
• Medical device registration to MoH.
• IDAK & CDAKB processes.
• Importation and LKPP Inaproc management.
• Strong understanding of Indonesian healthcare regulations and systems.
• Proficient in English (spoken and written).
• Full-time availability and commitment to grow with the company.

Responsibilities

• Ensure compliance with MoH regulations and standards.
• Develop and implement SOPs related to medical device registration.
• Prepare and manage product submissions based on device classification to MoH.
• Actively follow up and consult with regulatory authorities for approvals.
• Monitor and share updates on regulatory changes impacting business continuity.
• Handle OSS, IDAK, and CDAKB processes effectively.
• Manage importation and distribution processes aligned with regulatory standards.
• Oversee e-catalog submission process through LKPP or Inaproc.
• Participate in cross-functional projects and other regulatory-related tasks.

Skills

Regulatory affairs

Regulatory documentation

English proficiency

Education

Bachelor's degree or Professional Pharmacist qualification

Tools

IDAK

CDAKB

LKPP Inaproc

Job description

PT CONKOTE MEDICAL INDONESIA is seeking an experienced Regulatory Affairs Officer to ensure compliance with Indonesian health regulations and lead medical device submissions to the MoH. The role emphasizes technical leadership and cross-functional collaboration in a full-time capacity at our Central Jakarta operations.

Key responsibilities include developing SOPs for registration, managing OSS, IDAK, CDAKB processes, and coordinating LKPP/Inaproc activities.