Medical Device Regulatory Affairs Expert

10 hours ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $140,000

Job Title: Regulatory Affairs Specialist

About the Role:

This is a unique opportunity for an experienced regulatory professional to contribute to our 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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