• Regulatory Affairs Manager

    Posting Date 3 months ago(3/9/2018 2:03 PM)
    Requisition ID
    Job Location(s)
    Bloomington IN United States
    Shift Type
    Position Type
    Full Time
    Cook Medical Holdings
    Regulatory Affairs
  • Overview

    The Regulatory Affairs Manager manages the day-to-day operations of the Regulatory Affairs Team within an assigned product area or regional area to help ensure the process produces effective regulatory submissions and timely regulatory approvals.


    • Manage workload and workflow of assigned regulatory area
    • Communicate directly with RA leadership on proposed improvements
    • Manage submissions generated for their assigned regulatory area
    • Actively pursue ways in which to improve the function of the Regulatory Affairs Department
    • Communicate directly with regulatory agencies and distributors
    • Manage the progress of RA team members on assigned tasks, and remove roadblocks
    • Helps refine and implement Regulatory practices/procedures
    • Provide direction and logistical support to the RA team members to complete assigned tasks
    • Effectively communicate with and coordinate resources
    • Manage accountability within the team to meet established time lines
    • Accountable for managing and reporting metrics to the RA team
    • Responsible for performance and wage reviews for team members
    • Foster and maintain a workplace culture respectful and supportive of individual differences
    • 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
    • Implement policies, programs and directives of senior management
    • Interview, select and approve all training for employees
    • Make recommendations for staff and equipment and have significant input into personnel matters.



    Minimum Work Experience/Educational Requirements


    • Minimum 4 years Regulatory experience in the medical device field and/or 5 years Regulatory experience with Cook Medical.
    • Bachelor’s degree in a life science (preferably biology or life science) or other related field; or experience of such kind and amount as to provide a comparable background
    • Completion of RAC preferred

    • Proven project leadership skills.
    • Demonstrated ability to provide consistent leadership in a team setting
    • Demonstrated ability to manage conflict, communication & resources
      across multiple projects


    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
    • Sites for extended periods, utilizes close visual acuity for working with
      computers, etc.






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