Regulatory Affairs Specialist

18 hours ago

Noosa North Shore, Queensland, Australia Heng & Hurst Full time $90,000 - $120,000 per year

We're proud to partner with a global medical technology company on an ambitious journey to become one of the world's leading device manufacturers. Their diverse product portfolio features trusted, high-quality brands that are well-established in hospitals and healthcare settings.

Headquartered in Sydney and backed by a strong international network, the company is expanding rapidly through acquisitions and new product development. Their culture is collaborative, innovative, and driven by patient outcomes. Team members are empowered with autonomy, supported by global best practices, and inspired to think big.

As part of their continued growth, we are seeking a new Regulatory Affairs Specialist to join their team during an exciting period of transformation and innovation.

Reporting to a passionate, empowering and high performing Regulatory Affairs Manager, you'll support regulatory operations for Australia and New Zealand, contributing to product registrations, lifecycle management, and compliance initiatives.

This is a unique opportunity to be part of a growing team, gaining exposure to cutting-edge technologies while helping bring high-quality products to market.

Your key responsibilities will include:

  • Execute regulatory strategies and licensing activities to support product registration and compliance in Australia.
  • Collaborate with cross-functional and global teams to align regulatory requirements, review labelling, and ensure documentation accuracy.
  • Monitor regulatory changes and manage lifecycle maintenance of registrations, including submissions, renewals, and post-market activities across all classes of devices.
  • Participate in audits and support adverse event reporting and product safety monitoring.
  • Ensure compliance with regulatory procedures, quality systems, and coordination of necessary licenses and certifications.

To thrive in this role, you'll bring:

  • A tertiary qualification in science, engineering, or a related field
  • Experience in Regulatory Affairs within the medical devices industry (Class I–III)
  • A strong understanding of regulatory requirements in Australia and New Zealand
  • Excellent attention to detail and the ability to manage multiple priorities
  • A proactive mindset and a passion for innovation and collaboration

This is your chance to be part of a purpose-driven, high-growth business with a supportive team and strong global backing. You'll enjoy flexibility, autonomy, and the opportunity to make a real impact on the future of healthcare innovation across ANZ. This role will be a starting point of a potential long-term career as the product portfolio is extensive and meaningful.

To apply for this role please submit your application in WORD format by clicking  'apply'; or contact Sam Pickering on for further enquiries. Confidentiality is assured.

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