• Specialist, RAQA - Individual Contributor

    Job Location(s) US-CA-San Jose
    Posted Date 2 weeks ago(2 weeks ago)
    Job ID
    2018-29694
    Category
    Quality Assurance
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Responsibilities

     


    EUDAMED Data Analyst: 
    • Primary tasks include being responsible for supporting the implementation of Regulatory Affairs and Quality Assurance systems and procedures relating to international regulatory requirements that       will drive EUDAMED/UDI compliance 
    • Works with multiple functional representatives as well as EUDAMED/UDI subject matter experts to interpret requirements into processes. 
    • Serves as a team member for the EU MDR team; be responsible for working with other business units to provide guidance in the collection, review, and submission of data while ensuring that users   are properly trained and have the appropriate authorization. 
    • Works with the project team by gathering data from various departments, checking for data quality, and processing of change requests to facilitate submissions to EUDAMED/UDI 
    • Conducts the review of Quality System procedures and documents and provides administrative support especially submitting, tracking, and completing change orders 
    • Develops and maintains positive relationships with regulatory agencies through professional oral and written communications 
    • Documents and provides administrative support for regulatory deliverables

    Qualifications

    • 1-2 years of experience in an FDA regulated industry 
    • 2-3 years of experience in UDI 
    • Knowledge of EU MDR and MDSAP requirements and regulatory authorities such as TGA, ANVISA, HC, FDA, and MHLW is preferred 
    • BS in related field is required

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