Deskripsi pekerjaan
Posisi Supervisor QA bertugas untuk mengawasi operasional dan tim Regulatory Affairs, memastikan kepatuhan regulasi, serta memimpin peningkatan kinerja mutu secara berkelanjutan di perusahaan. Peran ini sangat strategis dalam menjaga standar kualitas produk alat kesehatan baik untuk pasar domestik maupun internasional. Tanggung jawab utama mencakup pengawasan terhadap tim Regulatory Affairs domestik dan luar negeri, pengelolaan kepatuhan regulasi dan dokumentasi teknis, serta komunikasi intensif dengan Kementerian Kesehatan. Selain itu, pemegang posisi ini harus memastikan kepatuhan terhadap regulasi TKDN dan kehalalan, mengelola persyaratan regulasi pasca-pasar, serta menerapkan pendekatan berbasis risiko dalam menyelesaikan berbagai tantangan regulasi perangkat medis.
Tanggung jawab: Supervise Regulatory Affairs (RA) Operations; Supervise Overseas & Domestic Regulatory Affairs Teams; Manage Regulatory Compliance and Documentation; Drive Quality Performance and Continuous Improvement; Ensure Compliance with TKDN and Halal Regulations; Post-Market Regulatory Requirement management.
Kualifikasi: Bachelor's Degree in Pharmacy or related field; 3 years of experience in Regulatory Affairs for Medical Device; Experience in Preparing & Communicating with Kemenkes; Proven experience working in Team Work; Strong knowledge about Regulatory Affairs Domestic & Overseas Analysis, Problem Solving for Medical Device; Cross-Functional Collaboration capability; Strong analytical skills with risk-based approach.
Tanggung jawab
- Supervise Regulatory Affairs (RA) Operations
- Supervise Overseas & Domestic Regulatory Affairs Teams
- Manage Regulatory Compliance and Documentation
- Drive Quality Performance and Continuous Improvement
- Ensure Compliance with TKDN and Halal Regulations
- Post-Market Regulatory Requirement management
Kualifikasi
- Bachelor's Degree in Pharmacy or related field
- 3 years of experience in Regulatory Affairs for Medical Device
- Experience in Preparing & Communicating with Kemenkes
- Proven experience working in Team Work
- Strong knowledge about Regulatory Affairs Domestic & Overseas Analysis, Problem Solving for Medical Device
- Cross-Functional Collaboration capability
- Strong analytical skills with risk-based approach
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Pendidikan
- S1
- Gaji
- Negosiasi