Job description for Regulatory Administration Officer at PT Semesta Indo Medika
PT Semesta Indo Medika (SIM) is an Indonesian medical device distribution company focused on bringing high-quality healthcare technology to hospitals and healthcare professionals across Indonesia. SIM provides end-to-end support to global medical device principals, including regulatory affairs, market access, warehousing, logistics and distribution, marketing, clinical support, and after-sales services.
We are looking for a Regulatory Administration Staff to support the regulatory and compliance activities of medical devices in Indonesia. The position will be responsible for assisting with product registration and licensing (CDAKB, IDAK), regulatory documentation, regulatory submissions, monitoring applicable regulations, and ensuring compliance with applicable Ministry of Health and other relevant regulatory requirements.
Key Responsibilities:
- Assist in medical device registration and licensing processes (i.e. CDAKB, IDAK).
- Prepare, review, organize, and maintain regulatory documentation.
- Support applications and submissions through relevant regulatory systems.
- Monitor changes in Indonesian medical device regulations and regulatory requirements.
- Coordinate with principals, internal teams, and relevant regulatory authorities.
- Ensure regulatory documents and product information remain accurate and up to date.
- Support compliance activities related to medical device distribution.
- Maintain proper regulatory records and documentation.
Qualifications:
- Minimum D3/S1 in Pharmacy
- Experience in Regulatory Affairs for medical devices, particularly in distribution, is an added value
- Understanding of medical device registration processes, IDAK, 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
- Integrity, Commitment, and Responsible
