Benefits

• Work with a world-leading medical device company making a difference in healthcare delivery.
• Permanent full-time role with competitive salary and benefits.
• Hybrid working environment – Sydney-based with flexibility.
• Exposure to global regulatory standards and cross-functional collaboration.

About the Company

This global medical technology organisation is a trusted leader in developing innovative solutions that improve the quality and efficiency of patient care. With a strong commitment to advancing healthcare, their state-of-the-art devices and products are used across the world. In Australia, they are renowned for their collaborative culture and investment in their employees' development.


About the Opportunity 

This company is seeking an experienced Regulatory Affairs Lead to project manage and execute regulatory strategies across Australia and New Zealand. In this pivotal role, you will ensure compliance with TGA and Medsafe regulations while working closely with regional and global stakeholders to support new product introductions and maintain market access. The role is key to driving compliance with evolving regulatory standards, while supporting continuous improvement and post-market activities.


Duties

• Lead regulatory submission strategies for product registrations, renewals, and amendments.
• Develop, maintain, and update technical files in alignment with product design and regulatory changes in compliance to TGA and Medsafe
• Review and approve advertising and promotional material to ensure regulatory compliance.
• Provide expert regulatory input for quality process improvements
• Collaborate with R&D, quality, clinical, and marketing teams to ensure compliance and project delivery.
• Drive process improvement and maintain document lifecycle management.
• Mentor junior team members and provide internal training on regulatory best practices.
• Monitor regulatory changes and update internal stakeholders on impacts to product lifecycle.

Skills and Experience

• Tertiary qualification in Science, Engineering, or a related healthcare field.
• Minimum 5 years' experience in Regulatory Affairs within medical devices, ideally Class IIb or III.
• In-depth knowledge of TGA and Medsafe regulations and regulatory frameworks including risk management, complaint handling, and post-market requirements.
• Strong written and verbal communication skills.
• Excellent project management and stakeholder engagement ability.
• High attention to detail with strong documentation and organisational skills.

Culture

You’ll join a dynamic and agile organisation with a clear purpose and inclusive, values-led culture. The environment encourages innovation, supports professional development, and values the impact each team member makes on improving patient safety globally.