• Regulatory Reporting Specialist

    Posting Date 1 month ago(12/11/2018 3:52 PM)
    Requisition ID
    Job Location(s)
    Bloomington IN United States
    Shift Type
    Position Type
    Full Time
    Cook Inc.
    Regulatory Affairs
  • Overview

    The Regulatory Reporting Specialist is responsible for the timely delivery of responses to inquiries from regulatory authorities.  The Regulatory Reporting Specialist coordinates with Regulatory Affairs, Regulatory Scientific Affairs, Quality Engineering, and other Cook companies globally in reviewing, preparing, and reporting adverse events to regulatory authorities. 


    • Based on information received, review regulatory reports, and develop and coordinate responses to inquiries from regulatory authorities
    • Review product complaints received from Cook global distribution centers
    • Plan, review, and prepare appropriate regulatory reports based on assessments
    • Collaborate with Regulatory Scientific Affairs 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 global 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

    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization
    • Must strictly adhere to safety requirements
    • Maintain regular and punctual attendance
    • Must maintain company quality and quantity standards
    • Must have effective oral, written and presentation communication skills
    • Ability to work in collaborative and independent work situations and environments with minimal supervision
    • Ability to remain calm and receptive in fast paced situations
    • Must have excellent analytical and problem solving skills




    Minimum Work Experience/Educational Requirements


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


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


    Physical Requirements/Work Environment


    • 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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