• RA / QA Specialist (Temporary)

    Requisition ID
    Experience Level
    Employment Status
    Temporary Full-Time
    Location : Location
    Engineering Operations
  • Overview

    Performs a variety of Quality Assurance and international regulatory activities that ensure compliance with FDA, EU and ISO regulatory requirements and reports to the Manager, Regulatory and Clinical Affairs.


    ·     Oversees and manages the Complaint process.

    ·     Facilitates the non-conforming material and Document Control process.

    ·     Coordinates Material Review Board (MRB) disposition with Quality Department, Purchasing, Engineering and Manufacturing as necessary.

    ·     Conducts material movement transactions from and to MRB/NCR (Non-Conformance Report) Inventory on the ERP System.

    ·     Maintains country specific registrations.

    ·     Supports international regulatory product submissions, e-Doc change control system administration.

    ·     Analyzing/trending and reporting of global quality data.

    ·     Provides support to Regulatory Affairs/Notified Bodies/FDA audits.

    ·     Processing regulatory documentation (e.g. notarization, apostilles, legalizations). 

    ·     Any other duties, as assigned by Manager, Regulatory and Clinical Affairs.


    • AA degree in RA/QA or applicable work experience
    • 6+ years in a Regulatory Affairs/quality assurance role at a medical device company
    • Supported international regulatory product submissions and 510k submissions
    • Participated in a Complaints process of reporting and tracking complaints
    • Supported CAPA (Corrective and Preventive Action) processes
    • Participated in QA/Regulatory cGMP/ISO 13485 audits

    Experience with filing eMDRs and Vigilance Reports


    • Must have good verbal & written communication skills
    • Strong ability to interact with multiple organizations to insure timely closure of complaints
    • Familiarity with FDA 21 CFR 820 and/or ISO 13485: 2016
    • Must be detailed & quality oriented and able to work independently with minimal directions

    Proven proficiency using Computer business software; such as, Microsoft Word and Excel (especially for graphing and trending purposes)


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