• Regulatory Affairs Scientist

    Posting Date 4 months ago(4/5/2018 12:25 PM)
    Requisition ID
    2018-4241
    Job Location(s)
    West Lafayette IN United States
    Position Type
    Full Time
    Company
    Cook Biotech Inc.
    Category
    Biomedical/Biotechnology
  • Overview

    The Regulatory Affairs Scientist at Cook Biotech, Inc. writes, reviews, submits and maintains technical documents related to: bench testing pre-clinical testing; clinical evaluations (including published and unpublished scientific articles from various sources); and submissions to regulatory agencies for the primary purpose of gaining approval or clearance to market medical devices.

     

    Responsibilities

    • Writes clear and accurate descriptions of testing and performance of medical devices suitable for regulatory agency review, including but not limited to: Clinical Evidence Reports (CERs), Investigational Device Exemption (IDE) requests, 510(k) Submissions and PMAs for US submissions or the equivalent set of documents for European submissions
    • Takes a supportable and defensible position on regulatory matters and writes with compelling logic and in a style appropriate for the reader
    • Reviews the work of peers
    • Prepares documentation for submission to regulatory agencies
    • Maintains records of technical documents sent to regulatory agencies
    • Develops and implements regulatory strategies for new and existing products

    • Serves as a company representative to the FDA and foreign regulatory authorities as required, both internally and externally
    • Assesses new technologies and practices for regulatory impact
    • Works closely with product development, pre-clinical, clinical and research teams
    • Manages projects and assures communications within and between project teams to provide guidance, issue resolution, insight, and strategic decisions
    • Provides well-reasoned and defensible opinion on matters of concern to the company by the application of not only scientific logic, but also judgment, wisdom, reason, practicality and insight

    Qualifications

    • Ph.D. in Biology (any additional relevant experience would be very highly considered) or a Master's degree with a minimum of 2 years of Biology.
    • Maintains knowledge of European, federal, state and local requirements applicable to the performance of regulatory affairs tasks related to pre-market submissions for medical devices, with specific expertise in either European or US requirements
    • Ability and interest in writing

    • Ability to rapidly learn new technical subject matter that may be unrelated to area if formal training
    • Ability to effectively and accurately communicate technical, medical and scientific information
    • Must be self-motivated and able to work with a minimum of supervision either alone or in a team environment
    • Must be able to lead others in a positive way in concert with the company’s vision

     

    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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