Associate Regulatory Affairs Systems Specialist
Core
Manage regulatory systems, submission workflows, and documentation tracking to support product registration and compliance across Southeast Asia.
Role type
Associate Regulatory Affairs Systems Specialist
Builds
Regulatory dossiers, submission packages, and compliance records for medical devices and healthcare products.
Domain
Healthcare / Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission coordination, documentation management, project timeline tracking, data accuracy verification, cross-functional stakeholder collaboration, translation coordination
Preferred skills
Medical device registration knowledge, Regulatory Information Management (RIM) systems experience, technical documentation preparation, multinational regulatory operations experience
Technologies
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Regulatory Information Management (RIM) systems
Responsibilities
Coordinate regulatory submission activities and project deliverables across Southeast Asia markets; Create, update, and maintain regulatory applications, events, and records within systems; Prepare and organize regulatory dossiers for product registrations and renewals; Track submission status and provide updates on regulatory projects; Partner with stakeholders to collect and verify regulatory documentation; Request and track regulatory certificates (CFGs, FSCs, ISO); Support translation activities for submission materials; Maintain accurate regulatory records and documentation.
Seniority
Junior, hands-on IC