Regulatory Affairs Specialist II - Lake Forest, United States - DivIHN Integration Inc

    DivIHN Integration Inc
    DivIHN Integration Inc Lake Forest, United States

    2 weeks ago

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    Job Description

    Job DescriptionFor further inquiries regarding the following opportunity, please contact one of our Talent SpecialistRashi | Title: Regulatory Affairs Specialist II - 3 Openings


    Location:
    Lake Forest, IL

    Duration: 12 Months    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.

    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 Client 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

    COMPETENCIES:
    Good knowledge of EU and international regulations.
    Demonstrated written and verbal communication skills.
    Strong time management skills, with the ability to work on multiple projects simultaneously.
    Ability to work independently as well as within a team.

    Proficiency with Microsoft Office, including Word, Excel, PowerPoint and VisioAbout us:DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond.

    The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
    DivIHN is an equal opportunity employer.

    DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.