- Ensure all company products are in compliance with local regulations
- Prepare, review and submit registration dossiers for new/extension, and changes in products for Indonesia market
- Liaise with local regulatory authority pertaining to registration and follow up with input requests from authorities until license obtained
- Maintain regulatory database(s), review and revise SOPs regularly
- Responsible for all CDAKB (GDPMDS) internal and external audits activities, and support compliance with any follow-up
- Collaborate cross functionality with other departments
- Provide regulatory advice/input to internal and external stakeholders
- Educational background in Pharmacy, Electromedical Engineering, or Medical-related disciplines
- Possesses CDAKB (Cara Distribusi Alat Kesehatan Yang Baik - GDPMDS) certification.
- Familiar with international standards like US FDA Quality System Regulations and cGMP, European Medical Devices, ISO 13485 Quality systems, etc., as well as HSA regulations and processes.
Join an integral position in a well-established multinational company. Great and challenging opportunity to mould your skillse
Michael Page