Global Product Compliance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
Post-Market Regulatory Consultant

We are seeking a highly skilled Regulatory Affairs professional to support our Post-Market Compliance efforts on a short-term, part-time basis during a critical period for the team. This is an excellent opportunity 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 to ensure effective collaboration and alignment with key stakeholders.
  • Prepare and implement post-market regulatory assessments to identify potential risks and opportunities.
  • Support medical device reporting (MDR) and post-market surveillance activities to maintain high-quality data and ensure compliance.
  • Monitor updates to global regulatory standards and ensure alignment with our existing processes and procedures.
Key Requirements
  • A degree in Engineering, Science, or a related field, preferably with a focus on Regulatory Affairs.
  • 6+ years' experience in medical device regulatory affairs, with a strong background in post-market activities.
  • Hands-on experience with regulatory submissions, including preparation of technical documents and responses to inquiries.
  • Excellent documentation, organizational, and stakeholder communication skills to effectively manage multiple projects and prioritize tasks.
Favorable Qualifications
  • Familiarity with EU MDR post-market surveillance and ISO 13485 to ensure alignment with industry best practices.
  • Experience working across multiple global markets, including the US FDA, TGA, and EU, to leverage expertise and knowledge.

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