Regulatory Affairs Expert

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000
Regulatory Affairs Role Overview

This position involves navigating regulatory landscapes for medical devices to support patient care in the UK and Europe.

Key Responsibilities
  • Develop and Implement Regulatory Strategies: Create and execute 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.
  • Provide Proactive Regulatory Guidance: Offer proactive 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: Lead Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.
  • Ensure Quality: Drive continuous improvement and maintenance of the Quality Management System (QMS) to ensure compliance.
  • Navigate Emerging Tech Regulations: Act as a key resource on the EU AI Act, interpreting and implementing AI governance obligations with subject matter experts.
  • 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 guidance from relevant authorities.
Requirements
  • 3-5 years of 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 PMS/PMCF activities, with understanding of relevant ISO standards.
  • Proactive, detail-oriented mindset with a commitment to quality and task 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.
  • A passion for quality and a proactive problem-solving mindset.
  • Fluency in English is required; proficiency in at least one other major European language is a benefit.
Why You Will Thrive
  • Flexible working environment, with a balance between office and remote work.
  • Additional paid time off for your birthday and wellness days.
  • Opportunity to learn from a diverse team of professionals.
  • Chance to create a global impact as part of a leading healthtech startup.
  • Fast-track your career with meaningful contributions.
  • Help transform healthcare in Australia and globally.
Seniority Level
  • Mid-Senior level
Employment Type
  • Full-time
Job Function
  • Information Technology and General Business
Industries
  • Software Development
  • Hospitals and Health Care

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