Advance Google’s advocacy for medical device features within the US by shaping regulatory policy. This pivotal role involves fostering executive-level relationships with agencies, preparing leadership for critical engagements, and representing company technical stances in industry coalitions and public forums. You will also collaborate internally to translate global health policy into actionable product guidance, ensuring swift and compliant market access for innovations.
Google for Health is dedicated to improving global well-being. We achieve this by integrating health solutions into daily life, supporting care teams, and leveraging technology to enhance health outcomes. Our efforts span from providing high-quality health information and tools to transforming care delivery and using AI for disease screening and diagnosis.
Lead and facilitate crucial engagements with Indian health authorities like the CDSCO, providing executive support and articulating Google's regulatory viewpoints.
Continuously monitor and dissect India's evolving legislative landscape, focusing on digital health, healthcare AI, and Software as a Medical Device (SaMD).
Represent Google in key US industry associations and standards organizations, including CTA Health, WHO-India, APAC med, and ISO committees, to cultivate collaborative policy initiatives.
Act as a liaison with internal engineering, clinical, quality, and government affairs teams, ensuring product claims are supported by robust clinical evidence and facilitating US marketing authorizations.
Offer expert regulatory policy counsel to leadership and partner with regional teams to ensure US policy efforts align with global digital health launch strategies.
A Master's degree in Science, Engineering, Software, Law, Public Health, Public Policy, or a related field, alongside equivalent practical experience, is required.
Possess at least 8 years of extensive professional experience in regulatory affairs.
Demonstrate a strong understanding of medical device standards, Software as a Medical Device (SaMD) frameworks, and proficiency in analyzing regulatory developments and authoring authoritative policy documents.
Exhibit experience leading government agency interactions beyond standard submission advocacy, and effectively educating global health authorities on advanced oversight frameworks for AI.
Proven ability to collaborate effectively with cross-functional clinical, quality, and engineering teams to harmonize product strategy with regulatory mandates.
Preferred qualifications include experience engaging with regulatory agencies outside of submission processes, expertise in digital health or AI policy (including generative models in clinical settings), and a track record of effective participation and contribution in international regulatory/industry forums and standards organizations, such as ISO/IEC and AAMI.
Healthcare