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Primary Function Writes, reviews, submits and maintains Cook Biotech technical documents related to: bench testing pre-clinical testing; clinical evaluations (including published and unpublished scientific articles from various sources); and submissions to regulatory agencies for the primary purpose of gaining approval or clearance to market medical devices. CER expert. Career Grid III.
Requisition ID
2022-10190
Job Location
West Lafayette IN United States
Category
Regulatory Affairs
Position Type
Full Time
Company
Cook Biotech Inc.
Location
US-IN-West Lafayette
An exciting career opportunity is currently available to join an organization involved in the research, design, and development of novel medical devices.  This job function will organize regulatory efforts throughout all phases of product research and development, and will author/co-author the necessary regulatory submissions to advance products to clinical evaluation or approval.  The function will primarily be involved with projects in early research and development phases, undergoing initial or early clinical trials both in the US and OUS.
Requisition ID
2021-9562
Job Location
West Lafayette IN United States
Category
Regulatory Affairs
Position Type
Full Time
Company
Cook Advanced Technologies
Location
US-IN-West Lafayette
The Regulatory Scientist is responsible for utilizing their scientific knowledge and regulatory acumen to fulfill premarket and postmarket regulatory requirements for medical devices manufactured by the Cook Group companies.  The Regulatory Scientist will coordinate with cross-functional teams to develop strategy for new medical devices and to support existing devices. Fully remote positions are available; however, the candidate is welcome to also work at the West Lafayette, IN Cook facility, if desired.
Requisition ID
2021-9526
Job Location
West Lafayette IN United States
Category
Regulatory Affairs
Position Type
Full Time
Company
Cook Research Inc.
Location
US-IN-West Lafayette