医療機器 安全管理業務

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

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.

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