Senior Regulatory Affairs Associate
Core
Ensures regulatory compliance for medical device products in the ANZ region by preparing submissions, maintaining technical files, and interacting with authorities.
Role type
Senior Regulatory Affairs Associate (Medical Devices)
Builds
Regulatory submissions and technical dossiers for medical device registration in Australia and New Zealand
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Regulatory submissions, Technical file management, Risk assessment, Post-market surveillance, Artwork/Packaging compliance, ISO 13485 knowledge, MDR knowledge, TGA/Medsafe framework knowledge, Class III Device Application experience
Preferred skills
Data Analytics/Reporting, Critical Thinking, Attention to detail
Technologies
TGA, Medsafe, ISO 13485, MDR
Responsibilities
Compile and submit regulatory submissions for medical devices; Develop and maintain regulatory documentation including technical files and design dossiers; Interact with regulatory authorities to address inquiries and resolve compliance issues; Perform post-market activities to support product compliance; Review artwork and packaging materials for compliance.
Seniority
Senior, hands-on IC