Medical Device Compliance Expert

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000

Key Job Role:

As a Regulatory Affairs Specialist, you will be responsible for ensuring the compliance of our medical devices with UK and EU regulations.

Responsibilities:

  • Develop and implement quality and regulatory strategies for product development and commercialisation in the UK and EU.
  • Manage the company's medical device readiness, taking a lead role in detailed MDR and UKCA conformity planning and execution.
  • Provide proactive regulatory guidance to cross-functional teams throughout the product lifecycle.
  • Oversee technical documentation, managing the development, compilation, and maintenance of UK/EU technical files.
  • Lead Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
  • Drive continuous improvement and maintenance of the Quality Management System (QMS) to ensure compliance.
  • Navigate emerging tech regulations, including the EU AI Act, and provide guidance on governance obligations.
  • Manage day-to-day interactions with UK and EU Notified Bodies, Competent Authorities, and external regulatory consultants.
  • Prepare and manage regulatory filings and applications.

Requirements:

  • 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices 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 PMS/PMCF activities.
  • Proactive, detail-oriented mindset with a commitment to quality and task completion.
  • Excellent communication and collaboration skills.
  • Bachelor's degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline.

What We Offer:

A flexible hybrid working environment, additional paid days off, opportunities for professional growth, and a chance to create a global impact as part of a leading healthtech startup.

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