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Software as a Medical Device Launch Enablement Lead

Company: Google Inc.
Location: Palo Alto
Posted on: November 19, 2021

Job Description:

Minimum qualifications: * Bachelor's degree in Life Science, Engineering, Business, or equivalent practical experience. * 8 years of experience in leadership/managing medical devices or product development/launches. * 5 years of experience in digital marketing, reimbursement and market access, software development, quality, medical/clinical, compliance data protection, and regulation. * Experience leading cross-functional organizations in a virtual, matrixed environment. Preferred qualifications: * Master's degree, MBA, or PhD in Life Sciences, Technology, or equivalent practical experience. * 6 years of experience with complex/transformational projects. * Experience using metrics as indicators of potential roadblocks, risks, and challenges. * Ability to influence technical teams without direct authority and drive decision-making through complex problem-solving. * Ability to take initiative and take complex challenges/processes and communicate them into practical terms. * Excellent communication skills. About the job In this role, you will support and partner with product teams to translate requirements for innovative digital health and global regulated Software as a Medical Device (SaMD) product launches. You will provide guidance and education to develop internal expertise and knowledge transfer for the processes and tools. You will maintain and iterate these centralized processes and tools to be evergreen for the changing environment while incorporating feedback from stakeholders. You will also develop program success criteria, metrics, governance, stage gates, communication, and cadence in collaboration with the product teams. In addition, this role will create scalable, repeatable, and innovative solutions that meet product team needs that are seamless to the users. At Google Health, you will drive project/team alignment and enable the success of these processes and tools that are essential to the successful development and launch that drives overall compliance and industry leadership. Google Health touches products and facilities across the globe. You will be the subject matter expert that will partner with functions, including Health Equity, Bioethics, Trust, Compliance, Health Information Privacy, Regulatory, Quality, and Clinical to liaise with product teams to develop and maintain a SaMD product development and launch enablement playbook. Responsibilities * Apply global product launch processes to SaMD product launches including inputs, timelines, governance, and deliverables from cross-functional partners. Manage multiple launches at once. * Provide thought leadership and expertise in quality, regulation, clinical, or compliance to develop a shared understanding of software launch processes in a regulated environment to drive capabilities by testing, learning, and adapting. * Partner with product teams to align on goals and success outcomes and gain team support on roles/responsibilities, governance, communication, and cadence. * Test and refine framework to ensure we have a consistent, effective, and scalable launch process and establish training programs to enable teams. * Explore other options to further test frameworks and build organizational capabilities.

Keywords: Google Inc., Palo Alto , Software as a Medical Device Launch Enablement Lead, IT / Software / Systems , Palo Alto, California

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