Regulatory Affairs Specialist
1 week ago
**Peran & Tanggung Jawab**:
- Bertanggung jawab atas proses registrasi AKL/NIE untuk produk Samsung Healthcare di Kementerian Kesehatan.
- Memastikan kepatuhan terhadap regulasi yang ditetapkan oleh Kementerian Kesehatan.
- Memantau dan memahami peraturan yang relevan sesuai dengan bisnis kesehatan.
- Menganalisis dampak perubahan regulasi terhadap perusahaan.
- Mengembangkan dan mengimplementasikan program untuk memastikan kepatuhan terhadap regulasi dari Kementerian Kesehatan.
- Menyiapkan dan memelihara dokumen terkait kepatuhan regulasi.
- Berkolaborasi dengan departemen lain di perusahaan seperti produksi, pemasaran, dan hukum untuk memastikan semua pihak mematuhi peraturan.
- Melakukan riset dan analisis terhadap tren regulasi yang sedang berkembang serta potensi dampaknya terhadap perusahaan.
**Persyaratan**:
- Minimal lulusan Diploma (D3) atau lebih tinggi, jurusan Manajemen, Administrasi Publik, atau Hukum Bisnis.
- Memiliki pengalaman kerja lebih dari 5 tahun di industri kesehatan.
- Memiliki kemampuan berbicara dan menulis bahasa Inggris tingkat menengah.
- Bersedia melakukan perjalanan dinas domestik dan internasional. Berdomisili di Jakarta.
Jenis Pekerjaan: Kontrak
Panjang kontrak: 3 bulan
Pertanyaan Lamaran:
- Berapakah usia anda saat ini?
- Dimanakah domisili anda saat ini?
Pendidikan:
- D1-D4 (Diwajibkan)
Pengalaman:
- Regulatory Affairs Specialist - Medical Devices: 5 tahun (Diwajibkan)
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