Senior Regulatory Affairs Specialist

16 hours ago

Sydney, New South Wales, Australia Heng & Hurst Full time

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 Senior Regulatory Affairs Specialist to join their team during an exciting period of transformation and innovation.

About The Role

Reporting to the Regulatory Affairs Lead, you'll manage regulatory activities across the US, EU, and Australian markets. You will play a critical role in supporting new product development, obtaining approvals, and managing post-market compliance, including surveillance and reimbursement submissions. This is a unique opportunity to be part of a growing team, gaining exposure to cutting-edge technologies while ensuring products meet global regulatory standards.

Key Responsibilities

  • Develop global regulatory strategies for new product development and submissions
  • Lead pre-submission meetings with FDA, Notified Bodies, and TGA as needed
  • Partner with clinical and cross-functional teams to support clinical strategy and investigations
  • Prepare regulatory submissions and technical documentation for approvals in the US, EU, and Australia
  • Manage lifecycle maintenance of products, including post-market surveillance, CAPAs, and regulatory impact assessments
  • Review labeling, marketing materials, and quality system change orders to ensure compliance
  • Monitor regulatory changes and maintain licenses, certifications, and compliance metrics
  • Act as a regulatory SME across audits, inspections, and cross-functional initiatives.

To thrive in this role, you'll bring

  • A bachelor's degree in science, biomedical engineering, regulatory affairs, or related field
  • 5+ years' experience in regulatory affairs within medical devices or healthcare
  • Good understanding of Prosthesis list and PLAC
  • Proven experience preparing submissions for US, EU, and TGA markets
  • Expertise in ISO 13485, ISO 14971, 21 CFR 820, and MTAA Code of Practice
  • Excellent attention to detail, analytical skills, and ability to manage multiple priorities
  • Strong communication, collaboration, and problem-solving abilities
  • A proactive mindset and a passion for innovation and compliance

Why Join?

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 offers exposure to pre-market, post-market, and reimbursement activities, providing a platform for long-term career development in regulatory affairs.

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

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