Responsibilities:

 •   Ensure compliance with regulatory agency regulations and interpretations

 •   Prepare responses to regulatory agencies' questions and other correspondence

 •   Organize and maintain reporting schedules for new device application and investigational new device applications

 •   Prepare necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides

 •   Provide solutions to a variety of problems of moderate scope or complexity

 •   Conduct searches of existing files for requested information

 •   Maintain and archive all regulatory documentation

Requirements:

 •   Minimum of 1,5-2 years of experience in Regulatory Affairs of medical devices (2a,2b,3 risk classes)

 •   Knowledge of FDA Regulations and CE Marking

 •   English - upper-intermediate

Working conditions:

 •   Annual contract with the possibility of extension

 •   Competitive salary, discussed in person

 •   Flexible working hours and advanced social package

 •   Career opportunities and international experience

 •   Professional team of like-minded people