Collabera UK | Digital Engineering and Talent Orchestration

Senior Regulatory Affairs Specialist

4 Years Experience : in Galway , in Ireland
  • Post Date: July 1, 2020
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Job Description

Key Skills & Experience:
• Bachelor’s degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
• Experience in Medical device or Pharma is essential
• Experience or working with regulatory files for USA / EU
• Lead projects/programs on own initiative and filed them
• Experience working directly with FDA, and notified bodies in the Europe
• Experience working with Class III medical devices or DMS Drug master file
• Experience filing using the ECTS system
• You are experienced with Microsoft applications including Word, Excel, Sharepoint, Teams, and knowledge of Adobe Acrobat, Data Management Systems are desirable

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