The Regulatory Reporting Specialist at Cook Medical is responsible for the timely delivery of responses to inquiries from regulatory authorities. The Regulatory Reporting Specialist coordinates with other functions within the organization, and other Cook companies globally in reviewing, preparing, and reporting adverse events to regulatory authorities.
• Review regulatory reports, and develop and coordinate responses to inquiries from regulatory authorities
• Review product complaints received from the AMER Support Center
• Plan, review, and prepare appropriate regulatory reports based on assessments
• Collaborate with Manufactures, as needed, on all high risk devices
• Communicate with other Cook companies globally, as necessary, for reporting
• Generate responses to inquiries on adverse event reports from various regulatory authorities
• May communicate directly with the regulatory authorities to ensure inquiries are received in a timely manner
• Generate various reports as requested from internal and external customers
• Bachelor’s degree in a related field required; nursing or biomedical engineering degree preferred
• Quality experience preferred
• Proven project management skills
• Requires occasional early morning or evening teleconferences
• Must be willing and able to travel as needed
• Works under general office environmental conditions
• Sits for extended periods, utilizes close visual acuity for working with computers, etc.