Innovative Healthcare Solutions Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
Job Description:

At the forefront of innovative healthcare solutions, our team is dedicated to revolutionizing the delivery of world-class care. As a Regulatory Affairs Specialist, you will play a pivotal role in navigating the intricate landscape of medical device regulations.

This position presents a compelling opportunity to make a meaningful impact in the healthcare sector. You will be responsible for crafting and implementing quality and regulatory strategies for product development and commercialization in the UK and EU.

Key Responsibilities:
  • Drive Regulatory Strategy: Develop and implement quality and regulatory strategies for product development and commercialization 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.
  • Be a Regulatory Champion: Provide proactive regulatory guidance to cross-functional teams throughout the product lifecycle.
  • Oversee Technical Documentation: Manage the development, compilation, and maintenance of UK/EU technical files, coordinating with internal teams and stakeholders.
  • Manage Post-Market Activities: Take the lead on establishing and managing Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
  • Ensure Quality: Drive the continuous improvement and maintenance of our Quality Management System (QMS) to ensure compliance.
  • Navigate Emerging Tech Regulations: Act as a key resource on the EU AI Act, working with subject matter experts to interpret and implement AI governance obligations.
  • Act as a Key Liaison: Manage day-to-day interactions with UK and EU Notified Bodies, Competent Authorities, and external regulatory consultants.
  • Own Regulatory Submissions: Prepare and manage regulatory filings and applications, taking ownership of the submission process under the guidance of the Head of Legal and Regulatory Affairs.

To excel in this role, you should possess 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices and ideally covering data governance, privacy, and emerging technology regulations like the EU AI Act. A strong ambition and readiness to lead projects and drive significant impact in a high-growth environment are required.

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