DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries. The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together. We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality. Project Description: The CDRH's Office of the Center Director (OCD) provides vision, leadership, and strategic direction for the Center regarding the regulation of medical devices and radiation-emitting products. The Total Product Lifecycle (TPLC) Advisory Program (TAP) is intended to simultaneously lower the risk for commercialization of medtech innovation and create better characterized, safer and more effective devices. It does this by communicating up front with downstream stakeholders whose support is required for commercialization, and by making the FDA approval process more efficient and responsive to sponsors. This communication transforms late-stage unknown / unmanageable risk to better understood early risk, where it is easier to manage and create strategic options. Success of this part of the TAP program depends on CDRH’s deep understanding of these downstream stakeholders, and our ability to communicate this understanding to sponsors of Breakthrough-Designated devices. This comprehensive understanding of the medtech innovation ecosystem and risk landscape is found in a select few independent private sector consultants, and our ability to utilize this expertise is critical. The objective of this contract is to provide the CDRH, the OCD, and the TAP with professional support services to support the development of content related to TAP training modules, work with the Agency to optimize the current processes, assess the value of the program and its return on investment (ROI), and to suggest improvements in program areas. Job Summary: The Agentic AI Developer to design, build, and deploy autonomous AI agent systems that augment human workflows and drive operational efficiency across our TAP programs.
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Job Type
Full-time
Career Level
Mid Level