Senior Medical Device Regulatory Policy Lead

• Coordinate and facilitate engagements with US health authorities such as the FDA, supporting leadership during high-level meetings and representing Google's regulatory positions where executive presence is needed.
• Monitor and analyze US legislative, statutory, and regulatory developments related to digital health, healthcare AI, and Software as a Medical Device (SaMD).
• Represent Google across key US industry trade associations and standards bodies, including CTA Health, AdvaMed Digital, and AAMI, to build collaborative policy coalitions. Draft authoritative white papers, policy briefs, and formal responses to federal RFI and public dockets.
• Liaise with internal engineering, clinical, quality, and government affairs teams to align device feature claims with necessary clinical evidence and support US marketing authorizations.
• Provide regulatory policy counsel to leadership and collaborate with regional leads to ensure US policy initiatives harmonize with global digital health launches.

Minimum qualifications:

• Master's degree in Science, Engineering, Software, Law, Public Health, Public Policy, a related field, or equivalent practical experience.
• 8 years of professional experience in regulatory affairs.
• Experience with medical device standards and Software as a Medical Device (SaMD) frameworks, and monitoring regulatory developments and composing authoritative policy briefs.
  
• Experience to lead government agency engagement outside of submission advocacy strategies and educate global health authorities on modern oversight frameworks for AI.
• Experience working cross-functionally with clinical, quality, and engineering teams to align product strategy with regulatory requirements.

Preferred qualifications:

• Experience in engaging with Regulatory agencies outside of submission.
• Specialized experience within digital health or AI policy; deep understanding of generative models in clinical settings.
• Track record of contributing to international standards (ISO/IEC, AAMI).
• Previous participation and proven effectiveness in international regulatory/industry forums/standards organizations.
  

• Master's degree in Science, Engineering, Software, Law, Public Health, Public Policy, a related field, or equivalent practical experience.
• 8 years of professional experience in regulatory affairs.
• Experience with medical device standards and Software as a Medical Device (SaMD) frameworks, and monitoring regulatory developments and composing authoritative policy briefs.
  
• Experience to lead government agency engagement outside of submission advocacy strategies and educate global health authorities on modern oversight frameworks for AI.
• Experience working cross-functionally with clinical, quality, and engineering teams to align product strategy with regulatory requirements.