Supervisor QA

About the role

Supervise Regulatory Affairs (RA) Operations, overseeing Overseas & Domestic Regulatory Affairs Teams. Manage Regulatory Compliance and Documentation, drive Quality Performance and Continuous Improvement, and ensure Compliance with TKDN and Halal Regulations.

Job Description :

• 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

Qualification :

• 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