Regulatory Affairs Manager
Core
Execute regulatory strategies and manage end-to-end submissions for ophthalmic devices, lenses, eye drops, cosmetics, and dietary supplements across APAC markets, ensuring alignment with global standards.
Role type
Senior Regulatory Affairs Manager (APAC Hub)
Builds
Regulatory dossiers, submission packages, and compliance frameworks for medical devices and related products in APAC.
Domain
Medical Devices / Ophthalmic Technology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
APAC regulatory strategy, EU MDR compliance, US FDA pathways, MDSAP audit preparation, lifecycle change management, RIMS data management, cross-functional collaboration, AI tool integration for regulatory workflows
Preferred skills
Experience with ophthalmic devices, drug-device combinations, cosmetics, and dietary supplements; virtual leadership of external consultants and local agents
Technologies
RIMS, Doc management systems, electronic submission portals (NMPA, PMDA, TGA, HSA, CDSCO, MFDS), AI tools for dossier compilation and gap assessment
Responsibilities
Define regulatory pathways and submission routes for APAC markets; lead electronic submissions via country-specific digital portals; assess regulatory impact of product and process changes; maintain RIMS data integrity and update APAC RA dashboards; collaborate with QA, R&D, and commercial teams on product development and audits; act as central contact for APAC country regulatory activities and provide guidance to external consultants
Seniority
Senior, hands-on IC with hub responsibilities
