Job DetailsFull-timeEstimated: $73,000 – $98,000 a year11 hours ago
Advanced degree or professional certification in medical device regulatory affairs
Experience in medical device standards development and compliance (e.g. AAMI, IEC, ISO)
Experience with the EU MDR including in relation to device classification, the GSPR, UDI, Vigilance/PMS, and clinical investigations
Experience with standalone SaMD mobile apps, wearable applications, or other consumer facing health solutions
Experience discussing with emerging market regulators such as TGA, PMDA, or ANVISA
Knowledge of clinical research methodology and providing advice to teams conducting clinical evaluations and investigations in accordance with the ISO 14155 and GCP
About the job
Google Health is seeking a Regulatory Affairs Specialist to join our team as we ensure our adherence to global medical device regulations and standards. Our aim is to build health technologies that improve lives and have a positive social impact.
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.
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 through 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, 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 regulatory authorization plans, including product requirements, clinical trials and regulatory communications and submissions, and communicate status updates, issues, and potential issues regarding regulatory plans, regulations, and standards to key stakeholders
Lead and prepare relevant regulatory dossiers required for regulatory registration and license applications
Ensure that existing approvals and documentation are maintained by monitoring product and labeling changes to assure adherence to regulatory 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.