• Regulatory Reporting Specialist

    Posting Date 2 months ago(3/8/2019 8:33 AM)
    Requisition ID
    2019-6084
    Job Location(s)
    Bloomington IN United States
    Position Type
    Full Time
    Company
    Cook Medical Inc.
    Category
    Regulatory Affairs
  • Overview

    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.

    Responsibilities

    • 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

    Qualifications

    • Bachelor’s degree in a related field required; nursing or biomedical engineering degree preferred
    • Quality experience preferred
    • Proven project management skills

     

    Physical Requirements:

    • 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.

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