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
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to supply sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.