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Summary: Ensures compliance with regulations and guidelines set by the US FDA. Specifically for Hemostasis IVD tests and laboratory instrumentation, which are used for patient clinical evaluations. Ensures that the Hemostasis instrumentation and diagnostic tests meet all applicable FDA regulations and guidelines. This includes preparing and submitting regulatory submissions, such as 510(k) premarket clearances, De Novo Classifications and Premarket Approval (PMA) applications, and ensuring they contain accurate and complete information. Contributes to the development of regulatory strategies for bringing devices to market or making changes to existing devices. This involves staying updated on FDA regulations, guidelines, and industry standards, and providing guidance to the development and manufacturing teams.
Essential Duties and Responsibilities:
Education and/or Experience:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
Full Time
$83k-107k (estimate)
08/17/2023
05/23/2024
stago-us.com
BUDD LAKE, NJ
1,000 - 3,000
1976
$200M - $500M