• Regulatory Scientist

    Posting Date 9 months ago(3/27/2018 5:07 PM)
    Requisition ID
    2018-4189
    Job Location(s)
    Bloomington IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Regulatory Affairs
  • Overview

    The Regulatory Scientist develops and prepares technical content of documents related to testing of Class III and higher complexity Class II medical devices submitted to regulatory authorities.

    Responsibilities

    • Must be able to rapidly learn new technical subjects and communicate technical and scientific information to project teams and regulatory authorities
    • Write clear and accurate descriptions of non-clinical testing and clinical studies of new medical products that will be used in support of FDA and Design Dossier submissions

    • Provide chemistry expertise, and work with internal and external partners to guide testing and chemical analysis of components
    • Review requisite critical data for completeness and suitability for submission to regulatory authorities domestic and abroad as required
    • Maintain knowledge of federal, state and local regulatory requirements applicable to pre-market submissions for medical devices
    • Develop and implement testing and regulatory strategies for new medical devices
    • Assess new technologies for regulatory pathways
    • Coordinate with product development, non-clinical and contract research organizations as needed for meeting project completion target dates

    • Collaborate with Vice President of Regulatory Scientific Affairs to achieve appropriate review, technical accuracy and submission quality as necessary
    • Provide leadership/mentoring for Associates and Specialists
    • 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

     

    • Ph.D. in Science or Engineering, or Masters degree with five years
      minimum experience with a preferred degree in a Biological Science,
      Anatomy or Biomedical Engineering
    • Basic understanding of statistical methods and analysis

     

     

    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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