Prior experience in pre-market regulatory review processes within the medical device industry, preferably with the FDA
Minimum of 6-8 years of experience as a Business Analyst
Solid proficiency with SQL for data querying and analysis
Experience understanding and analyzing medical device-related data
Ability to obtain and maintain a Public Trust clearance is required
Familiarity with Agile development methodologies and tools
Deep understanding of FDA regulatory processes and requirements, particularly as they relate to medical devices
Responsibilities:
Serve as a liaison between the Artificial Intelligence (AI) leadership team for medical devices, Data Science Team Leads, and Data Scientists
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)
Develop a working prototype or minimum viable product (MVP) designed to pilot various prioritized applications for the FDA
Assess the overall effectiveness of the tool and its impact on the FDA's Center for Devices and Radiological Health (CDRH)