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Product Labeling/Unique Device Identifier Manager, Google Health

Company: Google
Location: Palo Alto
Posted on: May 3, 2021

Job Description:

Minimum qualifications:+ Bachelors degree in life sciences or technology or equivalent practical experience. + 10 years of regulatory affairs/quality assurance experience at a medical device, pharmaceutical or biotechnology company.+ 10 years of experience with labeling (5 years UDI) and managing electronic tools that incorporate automated workflows (e.g., CARA and Veeva).Preferred qualifications:+ Advanced degree in life sciences or technology. + Establish processes for maintaining consistency of information. + Excellent interpersonal skills working across multiple divisions, sites and external resources.+ Experience leading global cross-functional teams. + Knowledge of customer service best practices. + Strong written and verbal communication skills. At Google were committed to improving the lives of as many people as possible. One of the most important areas in which were striving to do that is health. Today were studying the use of artificial intelligence to assist in diagnosing cancer, predicting patient outcomes, preventing blindness, and much more. Were exploring ways to improve patient care, including tools that are already being used by clinicians. And were partnering with doctors, nurses, and other healthcare professionals to help improve the care patients receive.The primary objective of the Quality, Regulatory, Safety and Trust (QRST) Operations team is to support the stakeholders focused on quality management systems (QMS) by developing and maintaining compliant systems and labeling processes.Google Health is building products and working with facilities across the globe. As such, the Product Labeling/Unique Device Identifier (UDI) Manager will build and refine the product labeling/UDI processes and capabilities while providing strategic guidance in the development and maintenance of the regulatory content of global labeling, symbols, and requirements.In addition, aided by the greater organization, you will create scalable and repeatable processes, solutions, and tools that appear seamless to our users through automation and integration. 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, youll help make this vision a reality.+ Develop and implement templates and systems for product labeling and documentation required to support new product launches, global initiatives and country specific configurations.+ Serve as a subject matter expert for European Union Medical Device Regulation (MDR) and United States Food and Drug Administration (FDA) labeling requirements including creation of a global UDI strategy and the implementation of that strategy following each countries requirements.+ Interpret EUDAMED and GUDID regulations and establish data systems to stay compliant.+ Maintain product labeling and create templates to ensure all FDA, Clinical and Laboratory Standards Institute (CLSI), Quality System, International and Organization for Standardization (ISO) requirements are met.+ Establish processes for maintaining consistency of information.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 ( .

Keywords: Google, Palo Alto , Product Labeling/Unique Device Identifier Manager, Google Health, Other , Palo Alto, California

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