[Quality] Safety Management Specialist/Manager [Shockwave]

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Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Chuo-ku, Tokyo, Japan

Job Description:

Position Overview

In compliance with MHLW ordinance 169 Quality Management System, MHLW ordinance 135 Good Vigilance Practice, FDA, European MDD/MDR and other applicable international regulations, the Safety Management Manager serves as a hands-on lead for Japan complaint handling, post-market surveillance, and regulatory reporting activities.

This is a playing-manager role with a high individual-contributor component: the incumbent personally owns a portfolio of complaints/adverse events, prepares and/or reviews regulatory reports, and ensures accurate documentation and on-time execution.

In parallel, the role provides technical direction, escalation support, and continuous improvement to strengthen compliance, inspection readiness, and cross-functional alignment with Japan and global stakeholders.

Essential Job Functions


* Independently handle a portfolio of Japan complaints/adverse events from intake through closure, including documentation, follow-up with reporters, and coordination of investigation activities.


* Perform initial assessment/triage, determine next steps, and serve as the escalation point for complex/high-risk cases; document reportability rationale and escalation decisions.


* Collect and verify required information (e.g., product/lot details, event narrative, patient impact), manage follow-ups, and coordinate product return logistics and vendor/repair partner communication when applicable.


* Draft, compile, review, and submit regulatory reports (e.g., MDR/MDV and other applicable reports) within required timelines; ensure supporting documentation is complete and inspection-ready.


* Work closely with cross-functional teams (Sales, Field, Engineering, Manufacturing, RA/QA, Clinical) and global counterparts to obtain technical input, complete investigations, and align on risk assessments and corrective actions.


* Maintain complaint/PMS metrics and perform trending and signal detection; prepare periodic summaries and ad-hoc analyses to suppor...