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About the Role

The Safety Management Manager serves as a hands-on lead for Japan complaint handling, post-market surveillance, and regulatory reporting activities, ensuring compliance with global regulations. This role involves managing a portfolio of complaints, preparing regulatory reports, and providing technical direction to strengthen compliance and cross-functional alignment.

Responsibilities

Independently handle Japan complaints/adverse events from intake through closure, including documentation, follow-up, and investigation coordination.
Perform initial assessment/triage, determine next steps, and serve as the escalation point for complex/high-risk cases.
Collect and verify required information, manage follow-ups, and coordinate product return logistics and vendor/repair partner communication.
Draft, compile, review, and submit regulatory reports within required timelines, ensuring supporting documentation is complete and inspection-ready.
Work closely with cross-functional teams 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.
Support internal/external audits and regulatory inspections by providing records, narratives, and evidence for vigilance/PMS processes.
Provide day-to-day technical guidance and knowledge sharing to team members and stakeholders.
Identify and execute continuous improvement opportunities across complaint handling, PMS, and regulatory reporting.
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.
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.
Proficient with computer-based applications (MS Word, MS Excel, MS PowerPoint) and complaint handling databases/systems.

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

Location

Chuo-ku, Tokyo, Japan

Work Type

Full-time

Experience Level

5+ years

Education Level

Bachelor's degree

About the Company

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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.