The role supports three key business areas within ANZ including FMC Devices/Medicines, Packs, and Seating while ensuring continuous product supply
Job Summary
The role supports three key business areas within ANZ including FMC Devices/Medicines, Packs, and Seating while ensuring continuous product supply.
As the Primary LSO for ANZ, the incumbent is responsible for assessing safety events and managing direct communications with the TGA regarding post-market surveillance.
The position requires leading the preparation and submission of registration applications for medicines with the TGA & Medsafe to drive commercial initiatives.
Matching Summary
The role supports three key business areas within ANZ including FMC Devices/Medicines, Packs, and Seating while ensuring continuous product supply.
Skills & Requirements
Must-have
3+ years regulatory affairs experience
Medical device and medicine applications
TGA and Medsafe submission expertise
GMP and ISO 13485 knowledge
Post-market surveillance and incident reporting
Nice-to-have
Pharmaceutical industry background
CE marking and MDR experience
Strong cross-functional collaboration skills
Risk management technique proficiency
Experience with global quality systems
Key Requirements
Degree in science, engineering or healthcare
Minimum 3 years regulatory affairs experience
Direct experience with medical device conformity assessment