Regulatory Affairs Manager

As Regulatory Affairs country manager, to ensure that regulatory submissions and post-licensing compliance are executed for all Ceva products according to the local law; to coordinate the activities necessary to achieve and maintain appropriate permits, licenses and other documentation required to be in compliance with appropriate regulatory authorities. To apply the regulation to the company in order to make business smoothly, checking the artwork and approval for artwork label and leaflet; to develop and communicate with head office on the regulatory strategy and life cycle management of all products in the country. As Affiliate Quality Officer, ensure that a quality system is implemented and maintained, following all the specific responsibilities of this position. As Pharmacovigilance national contact, to manage the local Pharmacovigilance activities following the Corporate procedures, to follow the corporate procedures, to generate local procedures if required and to ensure that any additional local requirements are met. To ensure the activities continuity. As Public Affairs from Ceva affiliate, to support offensive and defensive regulatory work on their countries focused on the local regulatory affairs, through good networking with authorities and other third parties. To represent CEVA as the contact person for the local Authorities and other external partners.