Job Description

Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalised treatments.

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Visit us at medtech to see how your unique talents will help patients on their journey to wellness.

The Prospect n

To support our continued growth, we’ve created a new prospect 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 n

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- Preparing and submitting regulatory applications and documentation to support new product launches, product changes, and ongoing market access across ANZ
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- Maintaining regulatory compliance by managing product registrations, responding to regulatory authority requests, and supporting periodic reporting requirements
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- Providing regulatory guidance and expertise to cross-functional teams, supporting product development, business initiatives, and audit activities
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- Driving continuous improvement by contributing to regulatory best practices, leading process enhancement initiatives, and supporting team capability development
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- Building and maintaining effective relationships with regulatory authorities, industry groups, and internal stakeholders to support business objectives and regulatory outcomes
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About You nn




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

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All applicants must have rights to work in Australia.

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📌 Senior Regulatory Affairs Associate - MedTech, Sydney
🏢 Johnson & Johnson MedTech
📍 Sydney