Senior Medical Device Compliance Officer

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $150,000 - $250,000
Job Opportunity

We are seeking an experienced Regulatory Affairs Specialist to join our team. The successful candidate will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.

Main Responsibilities:

  • Prepare and facilitate international regulatory submissions, including those for Australia, the US, and other regions.

  • Solve complex registration and compliance challenges to deliver favourable regulatory and business outcomes.

  • Work collaboratively with 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.

Requirements:

  • Experience and knowledge in relation to either Australia, US or other major market's medical device or IVD regulatory requirements and regulatory approval processes.

  • Ability to learn and expand regulatory knowledge in other international jurisdictions.

  • Excellent interpersonal skills with the ability to influence and negotiate with key internal and external stakeholders.

This is an exciting opportunity to work with a talented team and bring cutting-edge AI technology to market. Our mission is to urgently scale global healthcare capacity using AI automation to elevate the care clinicians can provide.

About Us:

We are a problem-solving organization that uses AI technology to redefine what's possible in healthcare. Our goal is to raise the standard of healthcare for millions of patients every day.

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