Medical Device Regulatory Specialist

About the role The Digital Health Regulatory Quality and Strategy (DHRQS) team serves as advisors helping Google navigate the complex and evolving global health regulatory landscape. We focus on three primary pillars: providing the regulatory strategy and operational infrastructure to help product teams across Google build and launch regulated products globally; safeguarding Google’s core platforms and general‑purpose models from being unintentionally regulated or exposed to liability; and actively partnering with global health authorities to shape international standards and national policies, ensuring AI regulations balance innovation with safety. 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 prepare 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 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. 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. Benefits Health, dental, vision, life, disability insurance Retirement Benefits: 401(k) with company match Paid Time Off: 20 days of vacation per year, accruing at a rate of 6.15 hours per pay period for the first five years of employment Sick Time: 40 hours/year (increased to 69 hours/year for Seattle) including 5 discretionary sick days per instance Maternity Leave (Short‑Term Disability + Baby Bonding): 28‑30 weeks Baby Bonding Leave: 18 weeks Holidays: 13 paid days per year Compensation US: $144,000 - $209,000 (USD) + 15% bonus target + bonus + equity + benefits EEO Statement Google is proud to be an equal opportunity and affirmative action employer. We are committed to building a workforce that is representative of the users we serve, creating a culture of belonging, and providing an equal employment opportunity regardless of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), expecting or parents‑to‑be, criminal histories consistent with legal requirements, or any other basis protected by law. Google is a global company and, in order to facilitate efficient collaboration and communication globally, English proficiency is a requirement for all roles unless stated otherwise in the job posting. #J-18808-Ljbffr Google Inc.