5 years experience in the medical device, health IT, and/or pharmaceutical industry.
Experience in regulatory aspects of medical devices and quality management for digital health software (experience with the FDA).
Experience supporting regulatory submissions processes including having interactions with Regulatory Bodies.
Experience supporting product development teams (managing product technical and regulatory documentation).
Advanced degree in medicine/biomedicine (or other relevant scientific discipline).
Experience in regulatory affairs and quality standards compliance in relation to medical devices (class I, and above) including product submissions.
Understanding of the changes within the Software as a Medical Device regulations including in relation to device classification and regulatory pathways.
Knowledge of clinical research methodology (including clinical investigation design and biostatistics); information management; and medical writing (e.g. training and experience in medical writing, systematic review and clinical data appraisal).
About the job
At Google we’re committed to improving the lives of as many people as possible. One of the most important areas in which we’re striving to do that is health. Today we’re studying the use of artificial intelligence to assist in diagnosing cancer, predicting patient outcomes, preventing blindness, and much more. We’re exploring ways to improve patient care, including tools that are already being used by clinicians. And we’re partnering with doctors, nurses, and other healthcare professionals to help improve the care patients receive.
Our team includes experts who are leveraging expertise in AI, hardware, products, and more to solve the big challenges in healthcare to help people lead healthier, more productive lives. This team works closely with other groups within Google and across Alphabet.
As a Regulatory Affairs Specialist you will work closely with our Clinical, Regulatory, Research, Partner, Trial Unit, Engineering, Product, Design and Legal teams, providing guidance and support including: design verification, pre-clinical, and clinical studies, and lead proactive and continuous improvements for Regulatory Affairs and in support of the quality system, and communicate status updates, issues and potential issues regarding regulations and standards, or project roadblocks and work with the teams to resolve any issues arising from them.
Contribute to the development of strategies and supports submissions for complex products to gain approvals for commercial distribution and clinical research in various geographies.
Assist in the preparation of relevant regulatory documentations required for submissions to the notified body and new and ongoing license applications.
Ensure conformity of product in accordance with the quality management system before release.
Ensure that existing approvals and documentation are maintained by monitoring product changes to assure quality of design, development, manufacturing, and labelling.
Support the Regulatory Affairs Lead and Quality Lead to ensure that post-market surveillance obligations are met, and that requirements for submission of vigilance reports are complied with.
At Google, we don’t just accept difference—we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products and our community. 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.