Quality Safety Management Specialist/Manager - Shockwave

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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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 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.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy