• Regulatory Reporting Specialist

    Posting Date 5 months ago(10/29/2018 4:50 PM)
    Requisition ID
    2018-5584
    Job Location(s)
    Winston-Salem NC United States
    Travel
    Less than 10%
    Position Type
    Full Time
    Company
    Cook Winston-Salem
    Category
    Regulatory Affairs
  • Overview

    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.

    Responsibilities

    • 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

    Qualifications

    • 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.

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