Safety Management Specialist/Manager (Shockwave)

About the role

Johnson & Johnson is hiring a Safety Management Specialist/Manager in Chuo-ku, Tokyo, for its Shockwave business unit. The role leads Japan's complaint handling, post-market surveillance and regulatory reporting in line with MHLW ordinances 169 and 135, FDA, European MDD/MDR and other regulations. It is a hands-on, playing-manager position: the incumbent personally owns a portfolio of complaints and adverse events, prepares and reviews regulatory reports, and gives technical direction and escalation support.

Key responsibilities

• Handle a portfolio of Japan complaints and adverse events from intake through closure, including documentation, follow-up with reporters and coordination of investigations.
• Perform initial triage, escalate complex or high-risk cases, and document the rationale for reportability and escalation.
• Collect and verify product, lot and event details, manage follow-ups and coordinate product returns and vendor/repair partner communication.
• Draft, compile, review and submit regulatory reports such as MDR/MDV within required timelines, keeping supporting documents inspection-ready.
• Work with Sales, Field, Engineering, Manufacturing, RA/QA and Clinical teams and global counterparts on investigations, risk assessments and corrective actions.
• Maintain complaint and PMS metrics, trend data, detect signals and prepare periodic summaries and ad-hoc analyses.
• Support internal and external audits and regulatory inspections, help maintain procedures and SOPs, and implement corrective actions.
• Provide day-to-day technical guidance, contribute to training, and run continuous improvement on complaint handling, PMS and reporting (e.g. work instructions, templates, data quality, CAPA and change control).

Required profile

• Bachelor's degree (or equivalent) and 5+ years of experience in medical device safety/complaint handling, or an equivalent combination of education and experience.
• Demonstrated expertise in complaint handling, post-market surveillance and regulatory reporting for Class III/IV devices (Japan and/or global).
• Experience improving complaint/PMS/vigilance quality systems (CAPA, change control, inspection readiness).
• Excellent written and spoken English and Japanese, able to produce inspection-ready documentation.
• Strong ownership and ability to influence in a matrix environment.

Required skills

• Data analysis, trending and presentation skills.
• Proficiency with MS Word, MS Excel, MS PowerPoint and complaint handling databases/systems.