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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