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    Regulatory Specialist II #: - Alameda, United States - HireTalent group

    HireTalent group
    HireTalent group Alameda, United States

    3 weeks ago

    Default job background
    Description

    1 week ago Be among the first 25 applicants

    Exempt/Non Exempt: Non Exempt Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.Duties: 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. Prepares U.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.

    Seniority level

    • Seniority level

      Mid-Senior level

    Employment type

    • Employment type

      Contract

    Job function

    • Job function

      Legal

    • Industries

      IT Services and IT Consulting, Accounting, and Financial Services

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    Immediate hiring for Regulatory Specialist II Regulatory Compliance Specialist (Medicare / Medi-Cal) Regulatory Specialist II - Medical - W2 only Manager, Regulatory Affairs: Job ID- 1322

    Palo Alto, CA $140,000 - $150,000 1 month ago

    Redwood City, CA $150,801 - $207,351 2 months ago

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