Upgrade Post project

Senior Regulatory Affairs Specialist

Galway  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Key responsibilities:
  • Prepare FDA submissions including IDE supplements, IDE annual reports, Investigator Reports, and Pre-Subs
  • Compile regulatory documentation to support IRB submissions in US
  • Compile regulatory documentation to support Ethics submissions in Europe
  • Prepare CE submissions including Annual reports to Notified Bodies, Design Dossiers, Substantial Change Notifications and Clinical Evaluation reports
  • Assist prepare clinical reports from IDE, OUS and Post Approval Clinical Studies
  • Prepare and manage international regulatory submissions in accordance with commercialisation plan
  • Provide input to regulatory aspects of change control, non-conforming process
  • Provide a regulatory interface to clinical and marketing groups
  • Manage assigned aspects of the Quality System as required


    • Experience Required:
  • Minimum 5 years experience in Medical Device Regulatory Affairs
  • Experience compiling and submitting Regulatory filings, particularly to the US FDA (PMA's, 510(k), IDE supplements)
  • Previous IDE or clinical experience
  • High attention to detail
  • Bachelors Degree in a scientific or relevant field
    • Start date
    02/2015
    Duration
    6 months
    From
    Real Staffing
    Published at
    29.01.2015
    Project ID:
    842108
    Contract type
    Freelance
    To apply to this project you must log in.
    Register