Medical Device Quality Assurance Manager

2 days ago

Adelaide, South Australia beBeeRegulatory Full time $90,000 - $100,000

Regulatory Specialist Position

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Fertilis is reimagining IVF with world-first micro-medical technologies.

We are a fast-growing startup with global ambitions, and we're seeking a regulatory specialist who wants to grow with us. In this role, you'll take ownership of our Quality Management System, support our pathway to FDA and MDR approvals, and partner with our scientists, engineers, and operations to ensure our devices are safe, compliant, and ready for global markets.


You'll work closely with our team, external partners, and regulators, developing skills that will prepare you to step into a quality manager role. Responsibilities:

  • Maintain, improve, and embed our quality system to support a regulated medical device business.
  • Work with our regulatory specialists to prepare documentation for FDA, MDR, and TGA approval.
  • Partner with product development and production to ensure design control and compliance are built in from day one.
  • Navigate stakeholders across regulators, suppliers, and auditors.

About the Role
  • 3+ years' experience in medical devices, pharma, or life sciences quality/regulatory roles.
  • A strong understanding of ISO 13485 and global regulatory environments.
  • Detail-oriented, proactive, and comfortable working in a fast-moving startup environment.

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