Senior Regulatory Affairs Associate - MedTech, Sydney
Core
Ensure successful registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand.
Role type
Senior Regulatory Affairs Associate (MedTech)
Builds
Regulatory applications and documentation for new product launches and market access
Domain
MedTech / Medical Devices / Healthcare
Deliverable
client delivery
Required skills
Regulatory framework knowledge (TGA, Medsafe, ISO), project management, problem-solving, cross-functional collaboration
Responsibilities
Prepare and submit regulatory applications for new product launches and changes; maintain product registrations and respond to authority requests; provide regulatory guidance to cross-functional teams; drive process enhancement initiatives; build relationships with regulatory authorities and stakeholders
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