Regulatory Reporting Specialist

Posting Date 3 weeks ago(12/28/2020 3:39 PM)
Requisition ID
Job Location(s)
Winston-Salem NC United States
Less than 10%
Position Type
Full Time
Cook Winston-Salem
Regulatory Affairs


The Regulatory Reporting Specialist at Cook Winston-Salem is responsible for assessing complaints for Regulatory Reporting, which includes Adverse Event Reporting (MDR, Vigilance, etc.) and associated correspondence to applicable Regulatory bodies.


• Review and assess product complaints received from Cook global distribution centers
• Assess complaints for adequate information to determine if event meets Regulatory Reporting requirements
• Utilize appropriate complaint software systems for processing complaints to/from distribution centers and Quality Engineering Investigation functions
• Generate appropriate regulatory reports based on assessment
• Communicate with other Cook companies globally, as necessary for reporting
• Generate responses to inquiries on Adverse Event reports from various global regulatory authorities
• Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests
• Assist in coordination of Recall administration activities between manufacturer and distribution centers


• Bachelor's degree in a technical discipline or Communications, or equivalent work experience
• Computer experience required with working knowledge of Microsoft Office programs
• Proficient keyboarding skills

• General product knowledge
• Medical device industry regulatory requirements knowledge preferred


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