医療機器 安全管理業務

Job description

Primary Function of Position

The Senior 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. Review / approve the evaluation of local and overseas post-marketing safety information. Manage an outsourced contractor daily work. 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

Qualifications

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.