Telecommute Regulatory Affairs Manager
Fort Wayne, Indiana
2d ago

A contract research organization has a current position open for a Telecommute Regulatory Affairs Manager. Core Responsibilities Include : Preparing, submitting, and managing regulatory clearance applications required for product market approvals Preparing and submitting USFDA Regulatory submissions Submitting and managing domestic product listings Must meet the following requirements for consideration : Travel nationwide 7-

10 years of experience in regulatory and / or quality assurance in a IVD medical device development and manufacturing environment Expertise and understanding of Class III IVD product entry into the US market Specific experience with US submissions for Medical Device and IVD products.

Skilled at interfacing with the FDA / CDER / OIR Prior project management experience

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