- Bachelor's degree in health, physical sciences, engineering, or related field or equivalent practical experience.
- 7 years experience in global medical device regulations and quality management, specifically FDA (21 CFR Part 820, 812, 807) and EU MDD and MDR (ISO 13485, CE Marking)
- Experience in regulation of software as a medical device (SaMD), including the IMDRF SaMD regulatory oversight framework and the FDA Digital Health Center of Excellence guidances and programs
- Experience in project management, training, and working with cross functional and cross location software development teams
- Experience participating in regulatory audits and presenting technical subjects to regulators during pre-market reviews
- Excellent organizational, verbal and written communication skills
About The Job
Google Health is seeking a Regulatory Affairs Specialist to join our team as we ensure our adherence to regulatory standards. Our mission is to build and maintain a regulatory program to meet our obligations to patients, partners, regulators and to create and support safe and effective products for our users.
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.
Fundamental research is at the core of Google Health - the multidisciplinary team collaborates with partners to publish novel research in renowned scientific journals. They then work to apply this research into the medical field, whether through Streams, our clinical assistant app, or other clinical hardware and products developed in Google. Working alongside colleagues across Google, you’ll help make this vision a reality.
- Develop strategies and submissions for complex products to gain approvals for commercial distribution and clinical research in various geographies.
- Work with the product team to develop world-class approaches to clinical trials and evaluation, providing guidance and support including design verification, pre-clinical, and clinical studies.
- Lead and prepare relevant regulatory submissions required for product market authorization (FDA, EU Notified Bodies, etc) and license applications
- Ensure that existing approvals and documentation are maintained by monitoring product changes to assure quality of design, development, manufacturing, and labeling.
- Ensure that post-market surveillance obligations are met, and that requirements for submission of regulatory reports are met
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 this form .