Medical Device Compliance Expert

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $140,000

Job Description:

The Regulatory Affairs Specialist role involves navigating regulatory landscapes for medical devices to support patient care in the UK and Europe.

This includes developing and implementing quality and regulatory strategies for product development and commercialisation, managing conformity planning, and providing proactive regulatory guidance to cross-functional teams.

Key Responsibilities:

  • Drive Regulatory Strategy: Develop and implement quality and regulatory strategies for product development and commercialisation in the UK and EU.
  • Lead Conformity Planning: Manage the company's medical device readiness, taking a lead role in detailed MDR and UKCA conformity planning and execution.
  • Navigate Emerging Tech Regulations: Act as a key resource on the EU AI Act, interpreting and implementing AI governance obligations with subject matter experts.

Requirements:

  • Hands-on experience in regulatory affairs within the UK and EU markets, including medical devices and ideally data governance, privacy, and emerging technology regulations like the EU AI Act.
  • A strong ambition and readiness to lead projects in a high-growth environment.
  • Working knowledge of EU MDR 2017/745 and UKCA marking requirements, with familiarity with the EU AI Act as a plus.
  • Direct experience compiling technical documentation and managing post-market activities.
  • Proactive, detail-oriented mindset with a commitment to quality and task completion.

About Us:

We are a healthtech startup focused on delivering world-class care with AI-enabled solutions. We are committed to creating a global impact by transforming healthcare.

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