• RA Spec II

    Location US-CA-Irvine
    Requisition ID
    2018-8446
    # of Openings
    1
    Category
    RA
  • Overview

    Overview:

    The primary responsibilities are to support of global product registration activities to sustain and grow QSD revenue for new products,  support license modifications for product changes, and required registration renewals

    Responsibilities

    Responsibilities:

    • Domestic and international regulatory submissions to assure timely release of new products to market world wide.
    • Support international product registrations: license updates and renewals in accordance with country specific requirements.
    • Coordinate import/export activities for RA including SAP regulatory restricitions.
    • Support controlled substance exemptions and reporting activities.
    • Support of design validation and performance evaluation studies.
    • Create EU technical files, Initiate change requests, to create/ revise procedures, support labeling changes required under IVDR requirements.

    Qualifications

    Qualifications:

    • Bachelor’s degree in biology, chemistry, medical technology or related field.
    • Advance degree and/or Regulatory Affairs Certification are preferred.
    • Knowledge of QSD control products, manufacturing processes, quality documentatation, value assignment, and labeling is preferred.
    • 2+ years' experience in domestic and international regulatory compliance or the equivalent in the medical device industry.
    • Working knowledge of FDA and CE Mark requirements
    • Preparation of product technical files
    • Knowledge of product labeling requirements.
    • Preparation of regulatory submissions
    • International product registrations

    About Bio-Rad:

     

    Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

     

    Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results. 

     

    EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age Employer

     

    To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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