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Intuitive · Tokyo, Japan

# Compliance Specialist 2

Tokyo, Japan Legal & Compliance 

Listed on Intuitive’s official careers site. Posted September 24, 2025. Check that it is still open and apply there.
[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000083591995-compliance-specialist-2)

[OpenNash Jobs](https://jobs.opennash.com/) / [Intuitive](https://jobs.opennash.com/companies/intuitive/) / Compliance Specialist 2

## Job description

### 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.

## Qualifications

### 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.

## At a glance
- Posted by the employer: Sep 24, 2025
- First seen by OpenNash: Oct 13, 2026
- Last checked: Oct 20, 2026
- Listed for: Over a year
- Location: Tokyo, Japan[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000083591995-compliance-specialist-2)

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