Senior Medical Device Regulatory Policy Lead

Google LLC; Washington (District of Columbia); In loco; USD 171.000 - 247.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with company match

Paid Time Off: 20 days per year

Sick Time: 40 hours/year

Maternity Leave: 28-30 weeks

Baby Bonding Leave: 18 weeks

Holidays: 13 paid days per year

Descrizione del lavoro

Google LLC in Washington DC seeks a Senior Medical Device Regulatory Policy Lead to drive US policy for medical device features and health AI. You will manage executive-level agency relationships, prepare leadership for engagements, and articulate Google's regulatory positions in coalitions and public consultations while coordinating with Clinical, Engineering and Government Affairs teams.

You will influence global digital health launches, align policy with evidence, and help accelerate safe

Competenze

• Master's degree or equivalent practical experience in a related field.
• 8 years of professional experience in regulatory affairs.
• Experience with medical device standards and SaMD frameworks.
• Experience leading government agency engagement and educating global health authorities on oversight for AI.

Mansioni

• Coordinate and facilitate engagements with US health authorities such as the FDA and represent Google's regulatory positions in high-level meetings.
• Monitor and analyze US legislation and regulatory developments related to digital health and SaMD.
• Represent Google in industry associations and standards bodies to build policy coalitions and draft formal responses.
• Liaise with internal teams to align device feature claims with clinical evidence and support US marketing authorizations.

Conoscenze

Regulatory affairs

Stakeholder engagement

Cross-functional collaboration

Policy analysis

Formazione

Master's degree in Science, Engineering, Software, Law, Public Health, Public Policy, or related field

Descrizione del lavoro

Senior Medical Device Regulatory Policy Lead

Share Senior Medical Device Regulatory Policy Lead

Google Washington D.C., DC, USA

X In accordance with Washington state law, we are highlighting our comprehensive benefits package, which is available to all eligible US based employees. Benefits for this role include:

• 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

• 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.

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 force-multiplier, 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. 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. Individual pay is determined by factors including job-related skills, experience, and relevant education or training.

US: $171000 - $247000 (USD) + 20% bonus target + equity + benefits

• 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.

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. See also Google's EEO Policy , Know your rights: workplace discrimination is illegal , Belonging at Google , and How we hire .

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.

Equity is granted exclusively and discretionarily by Alphabet Inc. on the basis of an agreement concluded between you and Alphabet Inc. Alphabet Inc. is your sole contractual partner with respect to equity grants. GSU grants are not guaranteed, are discretionary, are subject to approval by the Alphabet Inc. board of directors or its delegate, the terms of the relevant Alphabet Inc. stock plan, and your grant agreement. They have no impact on statutory payments. Current or past grants do not confer an acquired right.