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Post-Market Regulatory Expert

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000
Post-Market Regulatory Expert

We are seeking a highly skilled Post-Market Regulatory Expert to support our Compliance efforts on a short-term, part-time basis during a critical period for the team.

This is an excellent opportunity for a seasoned regulatory professional to contribute meaningfully to our mission by ensuring continued product compliance across global markets.

About The Role:

  • Represent regulatory affairs on selected post-market cross-functional teams
  • Prepare and implement post-market regulatory assessments (e.g. FDA, TGA, EU Notified Bodies)
  • Support medical device reporting (MDR) and post-market surveillance activities
  • Monitor updates to global regulatory standards (FDA, EU MDR, ISO, IEC) and ensure alignment
  • Assist with special projects to support business continuity and compliance

What You'll Bring:

  • A degree in Engineering, Science, or a related field
  • 6+ years' experience in medical device regulatory affairs
  • Hands-on experience with post-market regulatory activities
  • Excellent documentation, organizational, and stakeholder communication skills
  • Comfortable working independently in a flexible, part-time consultancy model

Engagement Details:

  • Part-time (3 days/week)
  • 6-month contract
  • Remote Work
  • Immediate start preferred

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