Senior Regulatory Affairs Associate - MedTech, Sydney
Fuelled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalised treatments.
Visit us at medtech to see how your unique talents will help patients on their journey to wellness.
The Opportunity
To support our continued growth, we've created a new opportunity for a Senior Regulatory Affairs Associate in Sydney.
Reporting into the Regulatory Affairs Manager, you will play a key role in ensuring the successful registration, maintenance, and compliance of innovative medical technologies across Australia and New Zealand.
Responsibilities
Preparing and submitting regulatory applications and documentation to support current product launches, product changes, and ongoing market access across ANZ
Maintaining regulatory compliance by managing product registrations, responding to regulatory authority requests, and supporting periodic reporting requirements
Providing regulatory guidance and expertise to cross-functional teams, supporting product development, business initiatives, and audit activities
Driving continuous improvement by contributing to regulatory best practices, leading process enhancement initiatives, and supporting team capability development
Building and maintaining effective relationships with regulatory authorities, industry groups, and internal stakeholders to support business objectives and regulatory outcomes
About You




Degree qualified with minimum 3-5 years demonstrated experience in a regulatory role within medical devices
Knowledge and understanding of regulatory frameworks and standards including TGA, Medsafe and ISO
Strong organisation, project management and problem-solving abilities, with strong attention to detail
Proactive with a consultative approach, and the capacity to engage and work with cross functional teams
Excellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively
Why Choose Us
Competitive remuneration package
Continuous training and support
Inclusive, flexible, and accessible working arrangements
Equal opportunity employer supporting diversity and inclusion
Up to 18 weeks of parental leave to support new parents
4 days of volunteer leave to give back to the community
Option to purchase up to 2 weeks of additional annual leave for extra time off
Enjoy a dedicated Wellbeing Day to prioritise self-careGlobal Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities
Access to an Employee Assistance Program for personal and professional support
Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support
Life insurance coverage for added peace of mind
And much more...
All applicants must have rights to work in Australia.
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📌 Senior Regulatory Affairs Associate - Medtech, Sydney
🏢 Brighter Signals
📍 Sydney