Sr. Associate, Quality Assurance & Regulatory Affairs
Core
Ensure product compliance with global, local, and internal regulations and quality standards for medical devices and pharmaceuticals.
Role type
Senior IC Quality & Regulatory Affairs Associate
Builds
Market authorization, GMP compliance, regulatory submissions, and quality management systems for eye health products.
Domain
Medical Devices / Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality System management, Regulatory compliance (GxP, ISO 13485, 21 CFR part 820), GMP/GDP adherence, CAPA process, Risk management, Change control, Audit preparation, Regulatory intelligence, Non-conformance investigation, Root cause analysis
Preferred skills
Hong Kong DOH engagement experience, Cantonese fluency, Mandarin communication
Technologies
Standard software platforms
Responsibilities
Drive awareness of Quality System and regulatory requirements; Ensure product compliance with market authorization and GMP requirements; Participate in Quality Management System activities (self-inspections, supplier qualifications, management review); Participate in audits of GxP suppliers and lead external audit preparation; Contribute to regulatory strategies and plans for submissions and approvals; Monitor regulatory intelligence; Perform local labeling and promotional material review; Respond to regulatory requests; Support market actions (FSCAs, recalls) and report to Health Authorities; Perform non-conformance investigations and root cause analysis.
Seniority
Mid-level, hands-on IC
