• Regulatory Reporting Team Lead

    Posting Date 9 months ago(9/7/2017 11:18 AM)
    Requisition ID
    Job Location(s)
    Bloomington IN United States
    Position Type
    Full Time
    Cook Medical Holdings
    Regulatory Affairs
  • Overview

    The Regulatory Reporting Team Lead manages the workload of the Regulatory Reporting Specialists and Regulatory Reporting Coordinators within an assigned division of product families.  They are responsible for ensuring complaints and regulatory reports are assessed, processed and compliant to regulatory requirements and internal procedures. 


    • Ensure workload and workflow of assigned regulatory area is optimized
    • Communicate status of projects directly to Regulatory Reporting Management and other stakeholders
    • Actively pursue ways in which to improve the function of the Regulatory Reporting Department
    • Monitor the progress of the team members on assigned tasks, and remove roadblocks
    • Review regulatory reports for compliance and monitor the efficiency and effectiveness of the team
    • Work with Management to allocate resources sufficient to complete complaints in a timely manner
    • Provide direction and logistical support to the team members to complete assigned tasks
    • Foster accountability within the team to meet established time lines

    • Mentor and train new team members
    • 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 and written communication skills
    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
    • Ability to remain calm and receptive in fast paced situations


    Minimum Work Experience/Educational Requirements:


    • Minimum 3-5 year direct regulatory or equivalent experience
    • Proven project management and supervisory skills
    • Bachelor’s degree in nursing (or equivalent), life science (preferably biology or chemistry), engineering, or business; or experience of such kind and amount to provide a comparable background.
    • Nursing experience preferred

    • Certification or commensurate experience


    Physical Requirements/Work Environment:



    • General office environment
    • Sits for extended periods
    • Requires close visual acuity when working with computers, etc.
    • Requires occasional early morning or late evening teleconferences
    • International and domestic travel as required


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