• Regulatory Science Specialist

    Posting Date 3 weeks ago(10/3/2018 8:54 AM)
    Requisition ID
    2018-5425
    Job Location(s)
    Bloomington IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Regulatory Affairs
  • Overview

    The Regulatory Science Specialist assists in the preparation of routine and non-routine regulatory submissions of Class III and higher complexity Class II medical devices submitted to regulatory authorities. The Regulatory Science Specialist will interact with representatives from other functions and/or serve as the regulatory member on project teams.

    Responsibilities

    • Prepare regulatory product approval submissions for new and modified
    medical devices
    • Provide support to pre-clinical testing and clinical studies of new and modified medical devices
    • Review requisite critical documentation for completeness and suitability
    for submission to regulatory authorities, both domestic and abroad as
    required
    • Collaborate with Regulatory Scientists, Director, Regulatory Science and other technical staff to develop and implement testing and regulatory strategies for new and existing medical devices
    • Collaborate with Regulatory Scientists and Director, Regulatory Science to identify areas for developing technical expertise that would be utilized by various functions within Cook

    • 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

    Qualifications

    Minimum Work Experience/Educational Requirements

     

    • PhD in Science or Engineering, or Master Degree in Science or
    Engineering with 2+ years experience in regulatory applications in the
    medical device industry required
    • Preferred degrees include Chemistry or Biological Science,
    Anatomy/Physiology, or Biomedical Engineering

     

    Physical Requirements/Work Environment

     

    • Works under general office environmental conditions
    • Sitting for extended periods, utilizes close visual acuity for working
      with computers, etc.

     

     

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