Prepares and maintains regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurosurgical products, including Class III devices.
March 31, 2020
Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department.
April 14, 2020
Demonstrate strong capabilities to engage directly with Legal and Company leadership on strategy and be able to pivot to granular detail within working teams.
April 15, 2020
Lead scenario planning and implementation projects for integrated water, wastewater, stormwater, groundwater, reuse, and alterative water management programs that require in-depth knowledge of evolving regulations and new funding opportunities.
April 15, 2020
Manages all phases of the project life-cycle process, from conception/initiation through closing, in order to deliver a specified information technology or business product, service, system, or result within the constraints of the project scope, resources, time, and budget.
April 24, 2020
Create and project manage Regulatory Affairs activities both within Regulatory Affairs and across various involved disciplines including Clinical Development, Preclinical Development and CMC to establish and meet timelines.
May 17, 2020
Facilitates team communication, monitors the activities of the project team to ensure constructive team dynamics, effective communication and progress in conformance with project scope and timelines.
May 18, 2020