Compliance Specialist 2

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. Roles and Responsibilities:  Preparation and implementation of GVP in compliance with Japanese PAL.  Collection and first reviewer of local and overseas post-marketing safety information.  Complaint handling management for filings and prepare the customer letter.  Communication with head office on complaint cases for preparation of customer letter.  Support quality management activity and work with QA team to maintain the appropriate quality management system.  Prepare and maintain the appropriate SOP for post-marketing filing, complaint handling and quality management in a timely manner.  Continuous improvement and management of the safety/quality assurance process in accordance with Intuitive Surgical Product Development Process.  Work directly with regulatory agencies on safety/quality issues and submissions.  Documentation of Package Insert and PMDA web maintenance of Package Insert Skill/Job Requirements:  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. 当社は、法令に従い、全ての応募者について、その適性と能力のみを基準として公正に採用選考を行います。