Manager – APAC Regulatory and Market Access
Core
Lead regulatory strategy and market access for medical devices in Australia, serving as the primary point of contact for clients and coordinating with global teams.
Role type
Manager, Regulatory and Market Access (Individual Contributor)
Builds
Regulatory submissions, clinical trial documentation, and market access dossiers for medical device clients.
Domain
Medical Devices / Regulatory Affairs / Market Access
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Australian TGA submission expertise, clinical trial documentation (CTN/CTA), regulatory strategy (classification, COR reliance), vendor management, technical writing, project management
Preferred skills
APAC regulatory frameworks (China NMPA, Japan PMDA, Korea MFDS), FDA/EU MDR knowledge, cardiovascular/neurology/orthopedic device experience, business development support
Technologies
TGA framework, ISO 13485, MDSAP, Therapeutic Goods Act, Medical Devices Regulations
Responsibilities
Own Australian TGA strategy and submissions; prepare clinical trial documentation; deliver regulatory strategy work; support market access engagements; coordinate APAC programs; manage regional vendors; write and QC regulatory documentation; partner on business development
Seniority
Manager, hands-on IC