• Regulatory Engineer

    Posting Date 4 months ago(2/26/2019 5:12 PM)
    Requisition ID
    2019-5976
    Job Location(s)
    Spencer IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Regulatory Affairs
  • Overview

    The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA and international regulatory requirements.

    Responsibilities

    - Act as liaison to engineering functions globally and locally to provide technical support for Regulatory Affairs
    - Develop new, and refine existing, systems that provide the necessary information for successful submission to global regulatory bodies
    - Help align engineering procedures and project outputs with regulatory requirements
    - Assist various Regulatory Affairs staff with technical assessment and writing of regulatory submissions and responses to regulatory agencies
    - Prepare regulatory submissions for new products, product changes, and re-registrations, as required
    - Perform and/or coordinate required assessments for change orders and facilitate approval
    - Provide product knowledge and training for Regulatory functional unit
    - Coordinate regulatory initiatives and drive to completion
    - Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
    -Ability to understand the purpose of a Quality System, and to effectively and efficiently complete work within guidelines of the Cook Inc Quality System

    - 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 communication skills and ability to work in a 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

    - BA/BS Degree in an Engineering or Science related field required; or experience of such kind and amount as to provide a comparable background
    - Experience in a FDA regulated environment and/or medical device is preferred
    - Must have technical writing capabilities and strong verbal communication skills

     

    Physical Requirements/Work Environment

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

    -Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA

     

    ***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.

     

     

     

     

     

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