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