Minimum qualifications:- Bachelor's degree in a technical or scientific discipline.
- 8 years of experience in evidence control and QMS administration in a regulated environment.
- Experience in ISO 13485, IEC 62304, and ISO 14971 as they apply to software as a medical device and artificial intelligence products.
Preferred qualifications:- Experience in a startup or fast-growing technical environment.
- Experience managing the regulatory boundary between general-purpose infrastructure and regulated applications.
- Familiarity with integrating regulatory requirements into CI/CD pipelines and developer workflows.
- Generative AI/LLM Experience: Proven ability to leverage AI for automating QMS or evidence-related tasks.
- Demonstrated success in aligning Engineering, Product, and Legal teams on new compliance paradigms.
- Strong project management skills and attention to detail.
About the jobIn this role, you will operate at the nexus of the health ecosystem, technological advancement, and regulatory expertise to steer Google's platforms in supporting billions of individuals throughout their health experiences. You will get to work with the engineers and product builders along with clinicians who are passionate about applying technology in health.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: $144000 - $209000 (USD) 15% bonus target bonus equity benefits
Learn more about benefits at Google .
Responsibilities- Run the Quality Management System (QMS) process, ensuring evidence collection and control to meet statutory and regulatory requirements.
- Maintain a state of 'inspection readiness' through proactive evidence collection.
- Administer the evidence control system and associated processes.
- Coordinate logistics for external regulatory inspections and third-party audits to provide necessary evidence as required by auditors and inspectors.
- Collaborate with Engineering to translate contemporary technical workflows, such as code submissions and automated checks, into rigorous SaMD compliance evidence to support regulatory expectations.
