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 new 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 solid 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.

📌 Senior Regulatory Affairs Associate (Sydney)
🏢 Brighter Signals
📍 Sydney