Post-Market Compliance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $135,000 - $155,000
Regulatory Affairs Expert Sought for Post-Market Compliance

We're looking for a skilled Regulatory Affairs professional to support our Post-Market Compliance efforts. As a Post-Market Consultant, you'll work across various regulatory activities to ensure continued product compliance across global markets.

About the Role

This is an excellent opportunity for an experienced regulatory expert to contribute meaningfully to our mission by maintaining product compliance across global markets. You'll collaborate with stakeholders across Quality, Product Development, and Global Product Management, providing regulatory input, delivering key assessments, and supporting ongoing product lifecycle activities.

Key Responsibilities
  • 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
Requirements
  • 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
Benefits
  • Part-time (3 days/week)
  • 6-month contract
  • Remote Work
  • Immediate start preferred
What We Offer

We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thriving on innovative ideas. If this sounds like the right fit for you, apply now.

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