What you’ll be doing Creates the regulatory strategy for our early stage of development projects to drive first-in-human (FIH) and small scale trials (n= Directs and manages interactions with all Regulatory Agencies including the FDA, especially EFS studies,  and international agencies in support of these early clinical trials Collaborate with project engineers to ensure quality systems adherence, guidance, and documentation requirements for early stage development through FIH studies  Develop, adapt, and initiate regulatory strategies for efficient FIH studies of new medical device therapies developed by the incubator