Mgr QARA Regional
Core
Leads regulatory and quality activities for hospital consumables and cosmetics across Southeast Asia, ensuring end-to-end product compliance, registration, and QMS oversight.
Role type
Regional Regulatory Affairs & Quality Manager
Builds
Product registration dossiers, license maintenance, and quality management systems for hospital consumables and cosmetics in ASEAN.
Domain
Healthcare / Medical Devices / Cosmetics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory affairs strategy, Quality Management Systems (ISO 13485), internal auditing, adverse event reporting, label and advertising compliance, cross-functional collaboration, technical writing, regional regulatory intelligence
Preferred skills
Knowledge of ASEAN Medical Device Directive, US FDA regulation, EU Medical Device Regulation, Taiwan FDA, product design and manufacturing processes
Technologies
ISO 13485, 3PL warehouse systems, regional regulatory databases
Responsibilities
Prepare and submit product registration and renewal documentation to local authorities, maintain product licenses and update corporate databases, lead coordination of adverse events and Field Safety Corrective Action reporting, perform internal audits for self-assessments and regulatory inspections, handle product quality complaints and collaborate on investigations, monitor new regulatory requirements and provide impact assessments
Seniority
Manager, hands-on IC with team leadership
