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.