Regulatory Affairs Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000
Regulatory Affairs Expert

We are seeking a skilled Regulatory Affairs Manager to build and lead our regulatory affairs team.

The ideal candidate will have experience in software-as-medical-device and in-vitro diagnostic device regulations, as well as excellent interpersonal skills.

Key responsibilities include preparing international regulatory submissions, solving complex registration and compliance challenges, and establishing medical device/IVD technical files.

The successful candidate will have knowledge of major market's medical device or IVD regulatory requirements and regulatory approval processes.

Main Responsibilities:

  • Prepare and facilitate international regulatory submissions
  • Solve complex registration and compliance challenges
  • Establish and maintain medical device/IVD technical files
  • Review advertising material for regulatory compliance

What We're Looking For:

  • Experience in software-as-medical-device and in-vitro diagnostic device regulations
  • Excellent interpersonal skills
  • Ability to influence and negotiate with stakeholders

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