• Regulatory Affairs Coordinator - Sr.

    Job Location(s) US-CA-Fremont
    Posted Date 2 weeks ago(5/11/2018 10:55 AM)
    Job ID
    Position Type
    Contract (Full-Time)
    # of Openings
  • Overview

    This role is specific to the planning and implementation of MDR (Medical Device Regulation) and will be linked to project.


    • Responsible for supporting the implementation of Regulatory Affairs and Quality Assurance systems and procedures relating to Domestic and/or International regulatory requirements.
    • Provides administrative support to a department or individual.
    • Knowledge of applicable international regulations and standards (QSR, MDD to MDR, ISO 13485, CMDCAS, etc.) and willingness to train others in Regulatory Affairs Compliance/GMP-related topics.
    • Develop and maintain positive relationships with regulatory agencies through professional oral and written communications.


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