Senior Medical Device Regulatory Policy Lead
Bengaluru, Karnataka, Indiaonsitefull timeToday
About the job:
As a Senior Regulatory Policy Specialist reporting directly to the Senior Director of Digital Health Strategy, you will help drive Google’s advocacy in the US for medical device features. Serving as an essential partner and a catalyst, you will facilitate executive-level agency relationships, prepare leadership for high-level engagements, and represent company technical positions in industry coalitions, public consultations, and standards bodies. Additionally, you will collaborate closely with internal stakeholders across Clinical, Engineering, and Government Affairs to translate evolving global health policy into clear, proactive product guidance that accelerates safe, compliant market access.
Responsibilities:
Coordinate and facilitate engagements with Indian health authorities such as the CDSCO, supporting leadership during high-level meetings and representing Google's regulatory positions where executive presence is needed.
Monitor and analyze India’s legislative, statutory, and medical device 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, WHO-India, APAC med, and ISO committees, and other advocacy groups to build collaborative policy coalitions.
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.
Experience within digital health or AI policy and understanding of generative models in clinical settings.
Previous participation and proven effectiveness in international regulatory/industry forums/standards organizations.
Track record of contributing to international standards (ISO/IEC, AAMI).
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