Regulatory Reporting Specialist

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