• Regulatory Affairs Coordinator - Sr.

    Job Location(s) US-CA-San Jose
    Posted Date 1 month ago(4/27/2018 12:24 PM)
    Job ID
    2018-29245
    Category
    Other
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Overview

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

    Responsibilities

    • 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.

    Qualifications

    QUALIFICATIONS: 
    • 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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right job?

    We can recommend jobs specifically for you! Click here to get started.