Quality Safety Management Specialist/Manager (Medical Devices)

Location: Chuo-ku, Tokyo, Japan

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions focused on less invasive treatment and improved patient outcomes.

What you will do

• Handle Japan medical device complaints and adverse events from intake through closure, including follow-ups, investigations, documentation, and product returns.
• Assess reportability and risk, determine escalation needs, and manage complex or high-risk cases.
• Prepare, review, and submit MDR/MDV and other regulatory reports within required timelines.
• Coordinate investigations and risk assessments with Sales, Field, Engineering, Manufacturing, RA/QA, Clinical, and global stakeholders.
• Maintain complaint and post-market surveillance metrics, perform trending and signal detection, and prepare analyses for product and process improvements.
• Support audits and regulatory inspections, maintain procedures and SOPs, provide technical guidance, and implement continuous improvements.

Requirements

• Bachelor’s degree or equivalent, plus 5 or more years of medical device safety or complaint-handling experience.
• Expertise in complaint handling, post-market surveillance, and regulatory reporting for Class III/IV devices in Japan and/or global markets.
• Experience with reportability assessment, risk evaluation, end-to-end investigations, CAPA, change control, or inspection readiness.
• Strong data analysis, trending, presentation, written communication, and problem-solving skills.
• Excellent written and verbal communication skills in English and Japanese are required.
• Proficiency with Microsoft Word, Excel, PowerPoint, and complaint-handling databases or systems.

Culture & Benefits

• Full-time position within a global healthcare and MedTech organization.
• Cross-functional and international collaboration across Japan and global teams.
• Opportunity to contribute to quality-system improvements, training, compliance, and inspection readiness.
• Playing-manager scope combining individual complaint ownership with technical guidance and mentoring.