Safety Control Specialist / 社名非公開

ジョブNo.NJB1026508

職種	Safety Control Specialist
社名	社名非公開
業務内容	■Primary Function of Position: The Safety Control Specialist is responsible to insure timely post-marketing filings (GVP) and complaint handling filings. Maintain post marketing and complaint handling documentation with necessary filings and communications to appropriate parties. Communicate with government / regulatory agencies on a local basis. Support the quality management activity in cooperation with QA team. Prepare and maintain SOP for post-marketing filing， complaint handling and quality management.
求める経験	－Educated and trained for post-marketing and/or quality management duties. －Excellent ability to work in cross-functional environments. －Strong verbal and written communication skills， proven ability to translate technical documentation into effective regulatory documents. －3-5 years’ Experience working directly with the MHLW and other governmental agencies on Post marketing matters and/or Quality assurance matters. －Friendly， positive attitude which fosters cooperation. －Careful documentation of every step in a field action. －Careful follow up of information sent to users and regulatory agencies. －Understanding of Japan and international regulations regarding medical device safety / quality management.
語学力	英語力：中級
勤務地	東京都
年収	600万円 - 700万円
雇用形態	正社員（期間の定めなし）