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 https://www.jnj.com/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 Recent 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 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 (New South Wales)
🏢 Brighter Signals
📍 New South Wales