RAQA Associate
Core
Supports Regulatory Affairs and Quality Assurance functions for medical device product registrations and quality compliance.
Role type
Associate Regulatory and Quality Affairs Specialist
Builds
Regulatory submissions and quality management systems for medical technology products
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory document preparation, Quality Management System (QMS) maintenance, Complaint lifecycle management, UDI data management, Labeling review, MFDS regulation knowledge, KGMP/DGMP audit support
Preferred skills
Medical device industry QA experience, MFDS regulations expertise, KGMP requirements knowledge
Technologies
MFDS, KGMP, DGMP, UDI
Responsibilities
Prepare and submit regulatory documents for product registration, Maintain and update Quality Management System (QMS), Manage product complaints and adverse event reporting, Review product labeling and e-IFU for compliance, Coordinate with global HQ and cross-functional teams, Support QMS certification audits
Seniority
Entry-level Associate