Medical Device Regulatory Specialist

Minimum qualifications:

• Master's degree in Engineering, a related technical field, or equivalent practical experience.
• 5 years of experience in regulatory affairs and engagement with global regulatory bodies.
• Experience with medical device standards and software as a medical device frameworks.
• Experience monitoring regulatory developments and composing white papers or policy briefs.

Preferred qualifications:

• Experience at leading med-tech firms, having served as the Directly Responsible Individual (DRI) for innovative product launches.
• Experience within digital health or AI policy space, including deep understanding of how generative models are integrated into clinical settings.
• Familiarity with Cloud-native Quality Management Systems (ISO 13485) and AI-specific quality standards (ISO 42001).
• Deep understanding of international harmonization efforts such as IMDRF and the processes regulators use to develop policy and guidance in major markets like the US and EU.
• Proven track record of contributing to the creation of international standards through organizations such as ISO/IEC and AAMI.

About the job

The Digital Health Regulatory Quality and Strategy (DHRQS) team serves as the advisors helping Google navigate the complex and evolving global health regulatory landscape. Our team is at the forefront of defining how AI can safely and effectively transform healthcare. We focus on three primary pillars. We provide the regulatory strategy and operational infrastructure to help product teams across Google build and launch regulated products globally. We safeguard Google’s core platforms and general-purpose models from being unintentionally regulated or exposed to liability, ensuring a clear separation between regulated features and core business services and we actively partner with global health authorities to shape international standards and national policies, ensuring AI regulations balance innovation with safety.

In this role, you will operate at the nexus of the health ecosystem, technological advancement, and regulatory expertise to steer Google’s platforms in supporting billions of individuals throughout their health experiences. You will work with the engineers and product builders along with clinicians who are passionate about applying technology in health.

Google for Health is a company-wide effort to help billions of people be healthier. We work toward this vision by meeting people in their everyday moments and empowering them to stay healthy and partnering with care teams to provide more accurate and accessible care. Our teams are applying our expertise and technology to improve health outcomes globally – with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community.

Responsibilities

• Monitor and analyze legislative and regulatory developments related to AI and healthcare policy. Coordinate and facilitate professional regulatory engagements with regulators and policy makers and the preparation of formal submissions.
• Maintain expertise regarding emerging regulatory frameworks as they pertain to Medical Devices and Software as a Medical Device (SaMD).
• Liaise with engineering and clinical functions at Google to align regulatory claims with necessary evidence. Provide support to the Leadership during high-level meetings with regulators and contribute to international standards development.
• Conduct comprehensive monitoring and analysis of legislative and regulatory shifts in AI and healthcare policy.
• Compose authoritative white papers, policy briefs, and participate in formal responses to public consultations initiated by regulatory entities or standards development organizations.