Regulatory Affairs Manager

Collect and share with Corporate/ Campus on regulatory trends and developments in region/country of responsibility to actively anticipate any changes in the regulatory environment. Actively participate and influence direct regulatory industry association working groups to anticipate and influence changes which affect the approval of new products. Plan the submissions and other regulatory strategies according to local and corporate priorities Plan, execute and track locally and globally driven submission plans to achieve timely and compliant registrations for CEVAs products. Compile local submissions as needed. Manage the translation of submissions to local language and mock up review and packaging implementation according to local needs and regulations. Manage samples and reagents between the campus and the control authorities. Manage the response to LOQ in collaboration with corporate regional and technical experts and keep in touch with authorities in order to negotiate or reach the best result for Ceva. Execute activities and submissions for LCM activities in an area of responsibility and give the adequate support of local portfolio optimization/ management. Responsible to maintain a good track record of all submissions and national competent authority written/ verbal exchanges in collaboration with corporate to allow us follow up activities with full knowledge of past activities. Maintain an archive for documents and electronic files to maintain regulatory history of past activities