Expert Regulatory Compliance Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $180,000 - $240,000
Regulatory Affairs Manager

This role requires a professional with extensive experience in medical device and IVD regulatory requirements and approval processes. The ideal candidate will have a strong understanding of international regulations, including those in Australia, US, and other major markets.

The Regulatory Affairs Manager will be responsible for preparing and facilitating international regulatory submissions, solving complex registration and compliance challenges, and working within a multi-disciplinary team to ensure regulatory requirements are fulfilled.

  • Main Responsibilities:
  • Solve complex registration and compliance challenges with a focus on delivering favorable regulatory and business outcomes.
  • Prepare and facilitate international regulatory submissions (Australia, US, and other regions).
  • 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.

What We're Looking For:

  • Experience and knowledge of medical device or IVD regulatory requirements and approval processes in Australia, US, or other major markets.
  • Willingness to learn and expand regulatory knowledge in other international jurisdictions.
  • Excellent interpersonal skills to influence and negotiate with stakeholders for favorable outcomes.

Benefits:

  • Fully funded learning and development budget.
  • Opportunities for internal mobility and career growth.
  • Market-leading parental support.

About Us:

We are a leading provider of AI technology solutions that aim to redefine healthcare. Our team is passionate about making a real difference in lives through the application of cutting-edge technology.

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