Surgical Guides Regulatory Expert

9 hours ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
Lead Compliance and Regulatory Expert

We are seeking a skilled Surgical Guides expert to lead our compliance activities and ensure audit readiness for FDA 510(k) submissions and ISO 13485 audits.

This role requires direct surgical guide expertise to support regulatory requirements and milestone delivery.

Candidates must be able to collaborate with cross-functional teams to prepare documentation and processes for regulatory milestones.

Key Responsibilities:
  • Lead compliance activities and ensure audit readiness for FDA 510(k) submissions and ISO 13485 audits.
  • Utilize direct surgical guide expertise to support regulatory requirements and milestone delivery.
  • Collaborate with cross-functional teams to prepare documentation and processes for regulatory milestones.

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