Global Product Compliance Expert

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $170,000
Regulatory Compliance Specialist

About the Role:

This is an exciting opportunity to contribute to a company's mission by ensuring continued product compliance across global markets.

Main Responsibilities:

  • Represent Regulatory Affairs on cross-functional teams to support post-market compliance efforts.
  • Develop and implement post-market regulatory assessments, including FDA, TGA, and EU Notified Bodies.
  • Support medical device reporting and post-market surveillance activities.
  • Stay up-to-date with global regulatory standards, including FDA, EU MDR, ISO, and IEC.
  • Collaborate with stakeholders to ensure business continuity and compliance.

Your Background:

  • A degree in Engineering, Science, or a related field.
  • 6+ years of experience in medical device regulatory affairs.
  • Hands-on experience with post-market regulatory activities.
  • Strong documentation, organizational, and communication skills.
  • Familiarity with EU MDR post-market surveillance and ISO 13485 is a plus.

The ideal candidate will have experience working across multiple global markets, excellent adaptability, and prioritization skills.

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