Technical Responsible Person (TRP)

We are seeking a Technical Responsible Person (Penanggung Jawab Teknis) to oversee and ensure regulatory compliance related to our medical devices. This role is critical in maintaining the integrity of our operations, ensuring that all activities related to distribution, storage, and usage of medical devices comply with applicable national regulations.

Responsibilities

• Ensure compliance with MoH (Ministry of Health) regulations for medical devices
• Monitor product storage, handling, and distribution according to applicable standards
• Coordinate with regulatory authorities regarding product registration and reporting
• Support internal audits and quality system implementation
• Review technical documentation and ensure product traceability
• Act as the official liaison for technical regulatory matters in the company

Requirements

• Holds a valid STR (Surat Tanda Registrasi) or equivalent, as required by Indonesian regulations
• Preferably holds a Bachelor’s degree in Pharmacy, or related fields may also be considered
• Good understanding of regulatory requirements for medical devices in Indonesia
• Detail-oriented with strong documentation and reporting skills
• Able to work independently and maintain compliance under pressure