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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 support product and process improvement actions.
• Support internal/external audits and regulatory inspections by providing records, narratives, and evidence for vigilance/PMS processes; help maintain procedures/SOPs and implement corrective actions for findings as needed.
• Provide day-to-day technical guidance and knowledge sharing to team members and stakeholders; contribute to training content to ensure consistent complaint handling and reporting practices.
• Identify and execute continuous improvement opportunities across complaint handling, PMS, and regulatory reporting (e.g., work instructions, templates, data quality, CAPA/change control participation as applicable).
• Other duties as assigned.

Requirements

• Bachelor’s degree (or equivalent) and 5+ years of experience in medical device Safety/Complaint Handling; or equivalent combination of education and experience.
• Demonstrated expertise in medical device complaint handling, post-market surveillance, and regulatory reporting for Class III/IV devices (Japan and/or global).
• Ability to assess reportability, risk, and escalation needs and to drive investigations end-to-end in collaboration with technical and clinical stakeholders.
• Experience contributing to and/or driving improvements in complaint/PMS/vigilance-related quality system activities (e.g., CAPA, change control/DCO, inspection readiness).
• Strong data analysis, trending, and presentation skills; able to translate signals into actionable recommendations.
• Excellent written and verbal communication skills in English and Japanese; able to produce inspection-ready documentation.
• Strong ownership mindset and ability to influence in a matrix environment (working across functions, aligning stakeholders, and sharing know-how/mentoring as needed).
• Proficient with computer-based applications (MS Word, MS Excel, MS PowerPoint) and complaint handling databases/systems.

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