Medical Devices, Business/Systems Analyst – (Remote, US)
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About The Position
We are seeking an experienced Business/Systems Analyst with a strong background in SQL and premarket medical device regulatory processes to join our dynamic team. The ideal candidate will possess prior regulatory review experience, particularly in medical devices, and will be adept at drafting, presenting to stakeholders, and tracking activities related to business requirements development, concurrence, and feature integration into analytics applications. In this role, you will work alongside a multidisciplinary team that includes AI Program Managers, Directors of Software Engineering, Data Science professionals, and Scrum Masters. Your primary focus will be to serve as a liaison between the Artificial Intelligence (AI) leadership team for medical devices, Data Science Team Leads, and Data Scientists. You will facilitate and lead key business aspects and applications of AI solution development for one of our key clients, the U.S. Food and Drug Administration (FDA). Your expertise will contribute to developing a working prototype or minimum viable product (MVP) designed to pilot various prioritized applications for the FDA. Utilizing an Agile development framework, you will help develop this initial prototype before scaling it into a fully productionized tool ready for enterprise-wide deployment. A key part of your role will be to assess the overall effectiveness of the tool and its impact on the FDA's Center for Devices and Radiological Health (CDRH) in supporting their regulatory review of marketed medical devices and those seeking premarket approval.
