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    Regulatory Compliance Specialist - Scarborough, ME, United States - DivIHN Integration Inc

    DivIHN Integration Inc
    DivIHN Integration Inc Scarborough, ME, United States

    2 weeks ago

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    Description
    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm.

    Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.


    Title:
    Regulatory Specialist II
    End Time (AM/PM) : Monday - Friday

    In this role you will prepare documentation for EU Technical Files and international product registrations.
    2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

    BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

    Responsible for implementing and maintaining the effectiveness of the quality system.
    Supports manufacturing/operations day to day activities for change control.
    Provides consultation/advice to regulatory specialist for change control and product development.
    Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
    S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
    Handles regulatory activities involved in documentation,labeling,field support.
    Applies regulatory and technical knowledge to a wide variety of complex work assignments.

    Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

    Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
    Responsible for technical writing of files in accordance with In Vitro Diagnostic medical
    Provides regulatory support for diagnostic product development and commercial
    Develops regulatory strategies for products in development and for modified products to
    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.
    Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
    Conducts informational or training sessions for stakeholders.

    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.

    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.

    Good knowledge of EU and international regulations.
    Strong time management skills, with the ability to work on multiple projects simultaneously.
    Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
    This position will be working with the team to make sure (products from client) everything is in compliance

    Re:
    Education, At least a Bachelor's degree. Scientific background preferred.
    Cross functional, quality, randd to aid in the writing and compilation of these docs.
    Environment - Working with the Regulatory Team in SCR- small, team of 4 ppl.


    Travel:
    No travel

    Able to read and understand regulatory issues, technical jargon.

    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.

    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.

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