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Hoffman Estates

    Regulatory Specialist I - Hoffman Estates, United States - DivIHN Integration

    DivIHN Integration
    DivIHN Integration Hoffman Estates, United States

    6 days ago

    Default job background
    Description
    This job was posted by : For moreinformation, please
    For further inquiries regarding the following opportunity, pleasecontact our Talent Specialists

    Title:
    Regulatory Specialist I \ Location:

    Des Plaines, IL \ Duration: 8 Months

    Description:

    Exempt/Non Exempt:
    Non Exempt


    Years Experience:
    0-2 years regulatory experience and/or relevant industrialexperience typically with a quality, product-development/support, orscientific affairs function
    Must have 1-2 years of experiences in Medical Device Reg Affairs

    Skills:
    Knowledge of regulations and standards affecting IVDs and/orbiologics
    Have working knowledge in EU MDR
    Have working knowledge in Regulatory Change Assessments
    Have working knowledge in US and EU medical device submissions
    Work cross-functionally and in a matrixed environment
    Have experience with continuous improvement activities

    Education :
    BA Degree Required
    BS preferred in a technical discipline like biology, chemistry,microbiology, immunology, medical technology, etc

    Duties:
    Responsible for implementing and maintaining the effectiveness ofthe quality system.
    Supports manufacturing/operations day to day activities for changecontrol.
    Provides consultation/advice to regulatory specialist for changecontrol and product development.
    Provides regulatory direction/interpretation on team activities.
    Interprets and applies regulatory understanding to support ofproducts and teams.
    Prepares U.S. regulatory submissions and/or registration documentsfor international affiliates and government agencies worldwide.
    Handles regulatory activities involved indocumentation,labeling,field support.
    Applies regulatory and technical knowledge to a wide variety ofcomplex work assignments.
    Maintains and ensures compliance to the appropriate quality systemfor the specific medical device(s) designed or manufactured that theindividual supports.
    Ensures compliance to and is able to demonstrate knowledge of siteand division level policies and procedures.

    Assist the strategy implementation and operations for regulatoryaffairs activities, including preparing documents and deliverablesto supporting change notifications and submission activities ,license renewals etc.

    Working knowledge of the regulations including EU MDR would behelpful in understanding the regulatory requirements for IVDRimplementation.
    Identify opportunity for regulatory affair processes and drivechanges to completion.
    This position will be working with multiple business units todevelop, update, and improve regulatory affair processes.
    Additionally Provide tracking, reporting, and presentation tomanagement for the project activities

    #J-18808-Ljbffr
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