Regulatory Officer
Experience Staff
Full-Time
Working Mode : WFO
Not Displayed
Job 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
Job Requirements
- 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
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