Compliance Specialist 2

求人内容

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.

資格

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.

その他の情報

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