Medical Device Regulatory Specialist

Google Google · Big Tech · Washington, DC +1

This role focuses on navigating the global health regulatory landscape for digital health products, particularly those involving AI. The specialist will advise product teams on regulatory strategy, ensure compliance, and engage with global health authorities and standards bodies. The role requires expertise in medical device regulations, software as a medical device (SaMD) frameworks, and monitoring legislative developments in AI and healthcare policy. While the company is involved in AI for healthcare, this specific role is centered on regulatory affairs and policy, not direct AI/ML model development or deployment.

What you'd actually do

  1. Monitor and analyze legislative and regulatory developments related to AI and healthcare policy.
  2. Maintain expertise regarding emerging regulatory frameworks as they pertain to Medical Devices and Software as a Medical Device (SaMD).
  3. Liaise with engineering and clinical functions at Google to align regulatory claims with necessary evidence.
  4. Conduct comprehensive monitoring and analysis of legislative and regulatory shifts in AI and healthcare policy.
  5. Compose authoritative white papers, policy briefs, and participate in formal responses to public consultations initiated by regulatory entities or standards development organizations.

Skills

Required

  • regulatory affairs
  • medical device standards
  • software as a medical device frameworks
  • monitoring regulatory developments
  • composing white papers
  • policy briefs

Nice to have

  • digital health
  • AI policy
  • generative models
  • Cloud-native Quality Management Systems (ISO 13485)
  • AI-specific quality standards (ISO 42001)
  • international harmonization efforts (IMDRF)
  • ISO/IEC
  • AAMI

What the JD emphasized

  • regulatory affairs
  • medical device
  • software as a medical device
  • regulatory developments
  • policy