• Regulatory Affairs Coordinator - Sr.

    Job Location(s) US-CA-San Jose
    Posted Date 1 month ago(4/27/2018 12:24 PM)
    Job ID
    Position Type
    Contract (Full-Time)
    # of Openings
  • Overview

    1st Shift 8:00 AM - 5:00 PM Monday, Tuesday, Wednesday, Thursday, Friday


    • Primary tasks include being responsible for supporting the implementation of Regulatory Affairs and Quality Assurance systems and procedures relating to international regulatory requirements.
    • Conducts the review of Quality System procedures and documents and provides administrative support especially submitting, tracking, and completing change orders.
    • Knowledge of applicable international regulations and the willingness to train others in quality assurance/GMP-related topics.
    • Work with subject matter experts to interpret requirements into processes.
    • Develop and maintain positive relationships with regulatory agencies through professional oral and written communications. Revise, track, and complete quality system documentation via CO process.


    • 2-3 years of experience in a FDA regulated industry 
    • 2-3 years of experience in processing engineering change requests 
    • Knowledge of EUMDR and MDSAP requirements and regulatory authorities such as TGA, ANVISA, HC, FDA, and MHLW is preferred


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