Monitor maintenance quality and technical standards, ensuring all maintenance work complies with established guidelines, regulatory requirements, and best practices.
Obtain product registration approvals from relevant authorities in APAC according to organization's regulatory plan and strategy by compiling dossier as per local medical device regulations and collaborating closely with Headquarter Premarket team and authorities/distributors.
Root Cause Analysis & Corrective Actions: Lead investigations into quality issues, perform root cause analysis, and implement corrective and preventive actions for non-compliances detected.