Heidi Health

Regulatory Affairs Specialist

Heidi Health

full-time

Posted on:

Origin:  • 🇦🇺 Australia

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Job Level

Mid-LevelSenior

About the role

  • Develop and implement quality and regulatory strategies for product development and commercialisation in the UK and EU
  • Manage medical device readiness, leading detailed MDR and UKCA conformity planning and execution
  • Provide proactive regulatory guidance to cross-functional teams (Product, Clinical, Marketing) throughout the product lifecycle
  • Manage the development, compilation, and maintenance of UK/EU technical files, coordinating with internal teams and stakeholders
  • Establish and manage 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
  • Act as a key resource on the EU AI Act and work with subject matter experts on AI 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, owning the submission process under guidance of Head of Legal and Regulatory Affairs

Requirements

  • 3-5 years of hands-on experience in regulatory affairs within the UK and EU markets, including medical devices
  • Experience covering data governance, privacy, and emerging technology regulations like the EU AI Act (ideal)
  • Strong working knowledge of EU MDR 2017/745 and UKCA marking requirements
  • Direct experience compiling technical documentation and managing Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities
  • Solid understanding of relevant ISO standards
  • Strong ambition and readiness to lead projects in a high-growth environment
  • Proactive, detail-oriented mindset with commitment to quality and ability to drive tasks to completion
  • Excellent communication and collaboration skills to work with internal teams and external partners
  • Bachelor's degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline
  • Fluency in English; proficiency in at least one other major European language is a benefit
  • Applicants will be asked about Work Authorization Status and sponsorship needs in the application form