Deskripsi Pekerjaan
Informasi lengkap tentang posisi dan persyaratan
Ringkasan Yukerja
Lowongan Regulatory Affairs di Sinocare Healthcare Indonesia kami kurasi dari JobStreet (kategori Kesehatan). Perhatikan lokasi kerja (North Jakarta, Jakarta) sebelum melamar. Yukerja.com bukan pemberi kerja — lamaran diproses di situs sumber resmi.
Job Descriptions
· Manage end-to-end product registration (AKL, AKD, renewal, variation, amendment).
· Maintain IDAK, CDAKB, OSS/NIB and other company licenses.
· Coordinate with the Ministry of Health and other government authorities.
· Prepare and maintain regulatory documentation and technical files.
· Support product launch, importation, and licensing activities.
· Monitor regulatory changes and advise management on business impact.
· Support regulatory inspections and internal/external audits.
· Coordinate with HQ and cross-functional departments.
· Maintain regulatory databases and submit monthly status reports.
Requirements
· Bachelor's degree in Pharmacy, Biomedical Engineering, Public Health, Biology, Medical Laboratory
Technology, or related field.
· Minimum 10 years of experience in Medical Device Regulatory Affairs.
· Strong knowledge of AKL, AKD, IDAK, CDAKB and Ministry of Health regulations.
· Experience handling government inspections and product registration.
· Good communication skills in English; Mandarin is an advantage.
· Highly organized, detail-oriented and able to work independently.