Manager, Quality - Adverse Event Reporting and Field Action

Requisition ID:  34911  

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

The Adverse Event Reporting and Field Action Manager leads global vigilance and field action activities to ensure timely identification, evaluation, escalation, and reporting of adverse events and product performance issues for Terumo Blood and Cell Technologies (TBCT) medical devices. This role partners cross-functionally (Quality, Regulatory Affairs, Clinical/Medical, Engineering, Manufacturing, Supply Chain, Customer Support, and Legal) to drive compliant execution of reportability decisions, regulatory submissions, field safety corrective actions, and effectiveness checks, while strengthening systems, procedures, and metrics that support continuous improvement.

Essential Duties

• Lead adverse event intake and triage: Oversee receipt, processing, and documentation of complaints and adverse event information from all sources; ensure data quality, completeness, and timely follow-up.
• Case assessment and reportability: Drive consistent assessment of seriousness, expectedness (where applicable), causal relationship, and reportability across global jurisdictions; document rationales and maintain decision trees/guidance.
• Regulatory reporting execution: Ensure accurate and timely submission of reportable events to applicable authorities (e.g., FDA MDR, EU vigilance, UK, Canada, Australia and other markets as applicable) and to customers/partners where required.
• Field action leadership: Plan and manage field safety corrective actions (e.g., advisory notices, recalls, removals, corrections, software updates), including classification, strategy, communications, distribution controls, and closure.
• Cross-functional investigation coordination: Partner with Global Complaint Handling, Global Medical Safety, Manufacturing Engineering, Quality Engineering, Risk Management and R&D to ensure thorough investigations, risk evaluations, and root cause analyses; ensure alignment between vigilance conclusions, CAPA, and risk management outputs.
• Health hazard/risk evaluation: Coordinate health hazard evaluations and benefit-risk assessments supporting field action decisions and regulatory interactions; ensure traceability to risk management files.
• Regulatory authority interaction: Serve as a primary point of contact for vigilance/field action communications with regulators; support inspections, audits, and requests for information.
• Metrics and management review: Establish and report KPIs (timeliness, backlog, quality, recurrence, escalation, field action effectiveness); identify trends and drive improvements.
• Process ownership: Own and maintain SOPs/work instructions for adverse event reporting, vigilance, and field actions; ensure alignment to applicable standards and regulations.
• Systems oversight: Administer or provide process ownership for complaint handling/vigilance tools (e.g., eQMS modules); ensure proper configuration, validation, and user training in partnership with system owners.
• Training and competency: Develop and deliver training to internal teams and affiliates on intake, documentation, escalation, reporting timelines, and field action execution.
• Supplier and partner coordination: Manage vigilance interfaces with suppliers, contract manufacturers, distributors, and strategic partners; ensure clear quality agreements and timely data exchange.
• Audit readiness: Maintain inspection-ready records, including case files, communications, decision rationales, submissions, and field action documentation.