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    Regulatory Affairs Specialist - Santa Clara, United States - GForce Life Sciences

    GForce Life Sciences
    GForce Life Sciences Santa Clara, United States

    3 weeks ago

    GForce Life Sciences background
    Description

    Regulatory Affairs Specialist Santa Clara, CA

    Must be able to work on a W2

    Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.

    Key Responsibilities:

    Duties:

    • Assist in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel
    • Communicate issues to management through project management tracking and issue briefings
    • Maintain high visibility to internal and external stakeholders
    • Demonstrate a high level of effective verbal and written communication skills, including negotiation, influencing, and conflict management
    • Work constructively, decisively, and collegially with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs
    • Manage and track broad and strategic projects
    • Communicate effectively in writing crisp briefings and issue analysis
    • Work effectively in a team environment
    • Track and ensure timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities
    • Communicate regulatory requirements to project teams and internal customers effectively

    Qualifications:

    • Bachelors degree required in engineering or science, masters preferred
    • Minimum of 3 years of experience in regulatory affairs
    • Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA) or with EU and other international medical device regulation submissions
    • Hands-on experience with 510k submissions, or PMA/s or US Annual report or CE Technical documentation preparation
    • Ability to negotiate, influence, and manage conflict
    • Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry preferred, but not required
    • Ability to work constructively, decisively, and collegially with internal customers
    • Ability to manage and track broad and strategic projects
    • Demonstrated ability to write crisp briefings and issue analysis

    Term & Start

    • 12-month contract with possibility to extend
    • FT, M-F 40hr/week
    • Pay Rate: $49-54/HR K Annually)
    • Onsite in Santa Clara, CA
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