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

    Intellectt Inc
    Intellectt Inc Lake Forest, United States

    3 weeks ago

    Intellectt Inc background
    Upper Management / Consulting
    Description

    The position of Regulatory Affairs Specialist II is within our Infectious Disease business

    unit. In this role you will prepare documentation for EU Technical Files and international

    product registrations.

    This job description will be reviewed periodically and is subject to change by management.

    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

    Abbott 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.

    Thanks & Regards

    Pavani Chiluka

    Recruitment Lead

    Direct:

    Office: ; Ext: 221

    Intellectt Inc

    #517 Route 1 South, Suite 1115 Iselin, NJ 08830.

    --Email is the best way to reach me