Spearheading Regulatory Compliance

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000
Compliance Specialist

This role involves building and leading the compliance team to ensure regulatory clearances and compliance throughout the organization. The Compliance Specialist will use their regulatory science knowledge and passion for technology to bring cutting-edge AI-driven medical devices to market, positively impacting patient lives at scale.

Key Responsibilities
  • Prepare and facilitate international regulatory submissions (Australia, US, and other regions).
  • Solve complex registration and compliance challenges with a focus on delivering favorable regulatory and business outcomes.
  • Work within a multi-disciplinary team to ensure regulatory requirements are fulfilled.
  • Establish and maintain medical device/IVD technical files.
  • Facilitate adverse event reporting and field actions when required.
  • Review advertising material to ensure regulatory compliance.

The ideal candidate will have experience and knowledge of medical device or IVD regulatory requirements and approval processes in Australia, US, or other major markets. They must be willing to learn and expand regulatory knowledge in other international jurisdictions.

Requirements
  • Experience working with regulatory affairs teams.
  • Excellent interpersonal skills to influence and negotiate with stakeholders for favorable outcomes.

We're seeking an experienced professional to lead our compliance efforts and help shape the future of AI in healthcare. This is an exciting opportunity to join a rapidly growing company and make a real difference in lives.

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