Regulatory Specialist / Engineer III, RA

Role Overview

• Support RA with tasks related to EU MDR/IVDR Technical Files
• Provide continuous regulatory support and manage RA mailbox
• Work for regulatory activities in cooperation with the RA team
• Draft regulatory plans and verification reports
• Responsible for updating CE technical files for medical products
• Review and approve product development reports and other documents
• Provide general quality support to the organization

Requirements

• Minimum BA/BS degree in a scientific or engineering field
• At least 2 years of experience in a regulated industry (pharmaceutical or medical device)
• Strong working knowledge of US and EU Medical Device and In vitro Diagnostic requirements
• Analytical mind-set and a great ability to learn new professional fields and business processes
• Great ability to structured and goal-oriented manner
• Excellent communication and team-building skills

Benefits

• Health insurance
• Professional development opportunities