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    Regulatory Affairs Specialist - Lake Forest, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Lake Forest, United States

    1 week ago

    GForce Life Sciences background
    Description

    The position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations.

    TERM & START

    • 1-year contract starting 6/10/24 with possibility to extend
    • On-site in Lake Forest, IL
    • Pay Rate: $45-60/hr depending on experience and with HM approval
    • FT hours, M-F 8a-5p
    • Business Unit: Infectious Disease
    • Interview Process: Microsoft Teams (up to 2 interviews)

    RESPONSIBILITIES

    • Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
    • Provides regulatory support for diagnostic product development and commercial diagnostic products.
    • Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
    • Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
    • Researches and communicates scientific and regulatory information to write submission documents.
    • Compiles and publishes all material required for submissions, license renewals, and annual registrations.
    • Maintains approvals/licenses/authorizations for existing marketing authorizations.
    • Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
    • Develops internal procedures and tools.
    • Conducts informational or training sessions for stakeholders.
    • Organizes and maintains hard copy and electronic department files.
    • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
    • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

    QUALIFICATIONS

    • Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
    • 4+ years' experience in Regulatory Affairs role.
    • Strong knowledge of IVDR and EU regulatory requirements is required.
    • 1+ years' experience in an IVD or medical device manufacturing environment.
    • Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
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