Quality Management Expert

4 days ago

Adelaide, South Australia beBeeRegulatory Full time
Senior Quality Associate

This is an exciting opportunity to join a dynamic team as a Senior Quality Associate. In this role, you will be responsible for leading QMS operations, supporting regulatory pathways, and enabling product launch.

Key Responsibilities:

  • Lead QMS operations as the Management Representative - Maintain, improve, and embed our quality system to support a regulated medical device business.
  • Support regulatory pathways - Work with our regulatory specialists to prepare documentation for FDA, MDR, and TGA approval.
  • Enable product launch - Partner with product development and production to ensure design control and compliance are built in from day one.
  • Navigate stakeholders - Build strong working relationships across regulators, suppliers, and auditors.

Requirements:

  • 3+ years' experience in medical devices, pharma, or life sciences quality/regulatory roles.
  • Strong understanding of ISO 13485 and global regulatory environments.
  • Detail-oriented, proactive, and comfortable working in a fast-moving startup.
  • Willingness to grow and take on broader responsibilities as the company scales.

About You:

As a Senior Quality Associate, you will have the opportunity to work with a talented team to develop and implement quality systems that meet the highest standards. If you are a motivated and detail-oriented professional looking for a new challenge, please apply today.

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