Regulatory Affairs Manager
Core
Lead regulatory compliance activities for Abbott's Rapid Diagnostics division across Australia, New Zealand, and Pacific Islands, ensuring market access for medical devices and diagnostics.
Role type
Regulatory Affairs Manager
Builds
Innovative rapid diagnostic tests for infectious disease, cardiometabolic, informatics, and toxicology products
Domain
Healthcare / Medical Devices / Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submissions management, post-market surveillance, adverse event reporting, import permit management, clinical trial support, regulatory database maintenance, industry consultation representation, internal stakeholder training
Preferred skills
Quality Management Systems knowledge, complex regulatory interpretation, project management
Technologies
TGA Medical Device Regulatory Framework, regulatory tracking systems
Responsibilities
Manage product registrations and regulatory submissions; maintain product registrations throughout lifecycle; lead post-market surveillance and adverse event reporting; review promotional materials for compliance; manage import permits; monitor regulatory developments; serve as primary contact for agencies; support clinical trials; maintain regulatory databases; provide guidance and training to internal teams
Seniority
Mid-level, hands-on IC
