24 months in the following FDA regulations and requirements for medical device including 21CFR Part 801, 812 and 814; Quality Management System including Design Controls, 21 CFR Part 820 and ISO 13485; ISO 149712012, AAMIIEC TIR 80001222012 and IEC 6236612015; Clinical Validation requirements such as Good Clinical Practice GCP, 21 CFR Part 56 and 21 CFR Part 50; and Writing FDA submissions and understanding of Technical Standards for eCopies. Fulltime telecommuting allowed.

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