Global Recall Lead — Regulatory & Quality Champion

Terumo BCT, Inc.; Lakewood (CO); Hybrid; USD 108,000 - 135,000; Full time

Job summary

Terumo Blood and Cell Technologies in Lakewood, CO is seeking a Senior Global Recall Specialist to lead end-to-end product recalls, ensure FDA/regulatory compliance, and coordinate with global teams to protect patient safety.

You will manage recalls, containment, communication, and documentation per 21 CFR Part 7/806, ISO 13485, and related standards, building robust processes and leading cross-functional recall teams.

Qualifications

• Bachelor's degree in a science-related field or equivalent.
• 5+ years in Quality and/or Regulatory functions in medical devices or regulated industry.
• 2+ years managing Field Alert Reports/recalls and related processes.

Responsibilities

• Lead global product recalls, corrections, and removals end-to-end.
• Serve as primary liaison with FDA Recall Coordinator and regulatory bodies.
• Coordinate cross-functional recall activities to minimize customer impact.
• Maintain thorough, audit-ready documentation per QMS requirements.
• Develop recall training and improve readiness across global teams.
• Track KPIs and drive continuous improvement in recall processes.

Skills

Quality Assurance

Regulatory Affairs

Leadership

Education

Bachelor's Degree

Tools

WindChill

ERP

Job description

Terumo Blood and Cell Technologies in Lakewood, CO is seeking a Senior Global Recall Specialist to lead end-to-end product recalls, ensure FDA/regulatory compliance, and coordinate with global teams to protect patient safety.

You will manage recalls, containment, communication, and documentation per 21 CFR Part 7/806, ISO 13485, and related standards, building robust processes and leading cross-functional recall teams.