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Google Looking for Regulatory Affairs Specialist, Google Health at Palo Alto, CA Full Time
Minimum qualifications:
- Bachelor’s degree in health/physical sciences, engineering, a related field, or equivalent practical experience
- 7 years of experience in medical device regulatory affairs in global markets
- Experience with US and international regulation of software as a medical device
- Experience in the preparation/clearance of FDA 510(k) submissions and international medical device submissions
Preferred qualifications:
- Advanced degree or professional certification in medical device regulatory affairs
- Experience in medical device standard development and compliance
- Experience with device classification, power monitoring systems, and clinical investigations
- Experience with standalone software as a medical device, mobile apps, or other consumer facing health solutions
- Experience with discussing emerging market regulators
- Knowledge of clinical research methodology and providing advice to teams conducting clinical evaluations and investigations
About the job
As a Regulatory Affairs Specialist for Google Health, you will research health focused applications, from the use of artificial intelligence to assist in diagnosing cancer and predicting patient outcomes to apps that detect AFib and operate on consumer smartwatches. Our aim is to build health technologies that improve lives and have a positive social impact. In this role, partnerships enable users to benefit from data in ways that can drastically improve health and wellness, especially in the areas of sleep, stress, and cardiac health.
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.
Google Health has made major advances in healthcare research, such as detecting eye disease more quickly and accurately than experts, planning cancer radiotherapy treatment in seconds rather than hours, and working to detect patient deterioration before it happens with electronic records.
Responsibilities
- Develop strategies and submissions for regulated medical device products to gain approvals for commercial distribution and clinical research in various geographies.
- Work with the Product team to develop global market strategy for authorization plans (e.g., product requirements, clinical trials, regulatory communications and submissions) and communicate status updates and potential issues regarding plans, regulations, and stakeholders.
- Lead and prepare regulatory dossiers required for regulatory registration and license applications.
- Manage approvals and documentation by monitoring product and labeling changes to assure adherence to requirements.
- Ensure that post-market surveillance obligations are met and that requirements for submission of regulatory reports are compliant.
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.
