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Lake Forest

    Regulatory Affairs Specialist - Lake Forest, United States - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Lake Forest, United States

    2 weeks ago

    Intellectt Inc background
    Description

    Role: Regulatory Specialist II

    Location: Lake Forest, IL, Santa Clara, CA, Boston, MA

    Duration: 6-12 Months

    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 in order 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.

    BASIC QUALIFICATIONS | EDUCATION:

    • 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.

    PREFERRED QUALIFICATIONS:

    • 1+ years' experience in an IVD or medical device manufacturing environment.
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