Project Manager I
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About The Position
The Project Manager I role is a critical position within our organization, located in Santa Clara, CA. This position is responsible for managing and directing activities associated with small to large scale projects, particularly focusing on non-IT business applications and disciplines. The Project Manager will oversee all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle. This includes collaborating with project sponsors, business units, and users to identify project scope and focus, developing or monitoring project initiatives, and implementing project requirements, plans, processes, and tools. The Project Manager will assign, guide, and monitor project staff to ensure project success, delivering quality project solutions to business problems or issues within defined budgets and timelines. This role requires proactive project guidance and support throughout the project lifecycle, ensuring that all project activities are tracked, reported, and presented to management and users effectively. The position also involves supporting IVDR compliance activities, including the creation of technical files and post-market surveillance activities, as well as new product development documentation. Additionally, the Project Manager will handle on-market support tasks such as regulatory impact assessments and regulatory operations, including BUDI number updates, label reviews, and FDA laser reports.
