Quality assurance and regulatory affairs special

We are looking for an internationally oriented quality assurance and regulatory affairs specialist to support or fast growing business and international expansion.We have an opening due to maternity leave with the possibility to become a fixed member of the quality and regulatory team.Oticon Medical is a small Gothenburg based company.As a key member of a small energetic team you will be responsible for maintaining the quality management system and supporting the product development teams as well as marketing and sales organization with regulatory input.This includes; - Establishing products Technical File - Reviewing marketing material considering product claims - Communicate with regulatory authorities and preparing regulatory submissions - Leading risk management activities - Handling complaints - Preparing, implementing and supervising the compliance of quality procedures - Planning, documentation and monitoring of clinical trails We offer you the opportunity to join a young, enthusiastic start up team focused on the continued growth and expansion of our company.You will be working in a team but largely independently.