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Regulatory entails working with pharmaceutical or medical device companies on IND (Investigational New Drug) applications or 510k device submissions to obtain permission from the FDA to conduct clinical research and obtain clearance.
Technical Skills Needed:
Understanding of FDA regulations
Ability to understand underlying mechanisms of a product or drug
Collaborate with
Medical writers
Quality Engineers
FDA
Manufacturing Engineers
Important Skillsets: Ability to coordinate and lead, attention to detail, technical writing, communication skills
Example Project: "IND application for an anti-microbial combination product. Mainly responsible for informing the sponsor on FDA guidance regarding combination products, the testing and other documentation the FDA expects for similar products, support for FDA meetings, general timelines, and coordinating reviews"
Piece of Advice from a Duke BME Graduate: "Be confident, organized, and willing to dig through FDA guidances. The FDA puts out a lot of very useful and fairly specific information, most of the time you just need to find it"
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