• International Affairs Specialist

    Posting Date 4 months ago(1/19/2018 9:07 AM)
    Requisition ID
    2018-3647
    Job Location(s)
    West Lafayette IN United States
    Position Type
    Full Time
    Company
    Cook Biotech Inc.
    Category
    Regulatory Affairs
  • Overview

    The International Affairs Specialist at Cook Biotech Inc. will provide support to the International Affairs department at Cook Biotech Incorporated (CBI). The International Affairs Specialist prepares regulatory submissions including: writing, reviewing, filing and maintaining regulatory, clinical, and design control documents. The International Affairs Specialist may also interact and correspond with international regulatory agencies and/or external Cook partners.

    Responsibilities

    • Author high-quality regulatory documents for purpose of gaining and maintaining regulatory approvals in countries outside of the United States
    • Takes a supportable and defensible position on regulatory matters and writes with compelling logic and in a style appropriate for the reader
    • Interact, collaborate and provide regulatory advice to staff, both internal and external to the Cook organization, including those of marketing partners and third party distributors
    • Works closely with product engineering, medical sciences and domestic regulatory teams to ensure consistent regulatory communications

    • Remain current and apply the understanding of international regulations and standards, as well as Quality System requirements in carrying out duties
    • Offer ideas on the department’s strategic planning and organizing of international projects
    • Perform data entry duties in various computer databases
    • Mailing, faxing, scanning, copying, and filing documents related to regulatory submissions
    • Participate in Cook working groups as requested by CBI management
    • Assist Management with other corporate duties when required

    Qualifications

    • Bachelor's degree in Science or Engineering; Master's degree in Science, Engineering or Regulatory Affairs is preferred
    • Current Regulatory Affairs Certification or two (2) years of science, quality or international regulatory experience is preferred
    • Scientific and technical writing; making persuasive arguments in a cross-cultural setting
    • Excellent written, verbal and listening skills
    • Proficiency in a second language is preferred

    • Strong attention to detail and capable of forward-looking critical thinking and problem solving
    • Broad knowledge and respect of foreign cultures and norms
    • Strong organizational, follow-up and prioritizing skills
    • Capable of meeting project deadlines and goals
    • Experience in using computers for word processing, databases and spreadsheets applications
    • Able to handle multiple and changing priorities along with fluctuations in workload
    • Able to travel domestically and internationally

     

    Physical Requirements:

    • Must be able to perform the essential functions of the job, with or without reasonable accommodations
    • Limited exposure to hazardous chemicals used in the manufacture of the product

    • Physical demands are typical of an office and classroom environment

     

     

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