Note: By applying to this position you will have an opportunity to share your preferred working location from the following:
Mountain View, CA, USA; San Francisco, CA, USA; Washington D.C., DC, USA.
- Bachelor's degree in Biology, Biochemistry, a related field, or equivalent practical experience.
- 14 years of experience in regulatory affairs within the healthcare industry with a focus on medical devices, digital health, or Software as a Medical Device (SaMD).
- Experience in personnel management (e.g., recruiting, performance management, career development, compensation).
- Experience working in a global company and navigating cross-cultural collaborations.
- Experience leading and managing a team, ideally personnel managers and international employees.
- Understanding of the unique regulatory and quality challenges faced in the MedTech, BioPharma, or Life Sciences industries.
- Deep understanding of industry best practices including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
- Deep understanding of global health regulations including FDA regulations, HIPAA, and GDPR.
- Excellent communication, people and presentation skills, with the ability to effectively communicate complex regulatory information to both technical and non-technical audiences.
Google 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, accessible, and equitable 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.
The US base salary range for this full-time position is $221,000-$314,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google.
- Lead the team that develops and implements regulatory strategies to ensure compliance with global health regulations and standards for medical devices, with a focus on Software as a Medical Device (SaMD).
- Oversee regulatory submissions and interactions with regulatory agencies. Provide guidance to product teams so appropriate claims are made and ensure that marketing materials are reviewed before product launches.
- Provide regulatory guidance and support to cross-functional teams across the organization including product management, engineering, and clinical teams, ensuring that health regulatory expectations are met in all areas.
- Monitor changes in the regulatory landscape and assess their impact on Google Health products and services, while building and maintaining strong relationships with regulatory agencies and industry stakeholders.
- Ensure that safety, privacy, and regulatory evaluations are conducted systematically, and that meticulous records are maintained.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Google's EEO Policy and EEO is the Law. If you have a disability or special need that requires accommodation, please let us know by completing our Accommodations for Applicants form.