Regulatory Affair Consultant (PJT Medical Device)

Hiring for NCS Internal Team.

Responsibilities :

• Manage end-to-end licensing and regulatory processes for Medical Devices (Alkes) and Household Health Supplies (PKRT) across all applicable classes.

• Handle facility certifications, including IDAK & SS, CDAKB, CPAKB, and CPPKRTB.

• Manage product registration, E-Catalog listing, KFA Code synchronization, and Import Approval (SKI) processes.

• Ensure regulatory compliance and accurate data synchronization through OSS RBA, Regalkes, and e-Sertifikasi platforms.

• Coordinate professionally with relevant government authorities, including Ministry of Health (MOH) and BKPM.

• Monitor regulatory requirements, submission status, and approval processes to ensure timely completion.

• Maintain accurate regulatory documentation, records, and databases in accordance with applicable regulations.

• Provide regulatory support and guidance to internal teams and clients regarding Medical Device and PKRT licensing requirements.

Requirements :

• Minimum Bachelor’s Degree (S1) in Pharmacy, Electromedical Engineering, Law, or a related field.

• 1–2 years of experience in Medical Device and/or PKRT regulatory affairs; experience in a regulatory consultancy firm is a strong advantage.

• Proficient in handling OSS RBA, Regalkes, and e-Sertifikasi platforms.

• Good command of English, both written and verbal.

• Mandarin proficiency is a strong advantage.

• Possession of a PJT CDAKB Certificate is a strong advantage.

• Strong attention to detail, accuracy, and ability to manage multiple regulatory processes simultaneously.

• Able to work efficiently under tight deadlines and changing priorities.

• Strong communication and coordination skills, particularly when dealing with government authorities and clients.

• Available to join as soon as possible.