Regulatory Affairs Specialist

Requirements

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