Hiring: Senior Global Recall Specialist Company: Terumo Blood and Cell Technologies Location: Lakewood, CO Job Posted Time: 2026-09-10 13:44:15 Employment Type: Contract / Hybrid Target Skills & Keywords : Microsoft Excel, Microsoft PowerPoint, Quality Assurance, Regulatory Compliance, Root Cause Analysis, SAP, Swift About the job Experience: •5+ years of progressively responsible experience in Quality and/or Regulatory functions in the medical device or similar regulated industry. •2+ years of hands-on experience managing Field Alert Reports (FARs), recalls, and related processes in the pharmaceutical or medical device industry. •Demonstrated leadership experience in managing teams, projects, or functional areas. Required Skills: •Lead and manage the full lifecycle of global product recalls, corrections, and removals. •Identify affected products and lots using traceability tools and internal systems (e.g., ERP, WindChill). •Define and execute containment, communication, and distribution strategies based on risk assessments. •Draft and implement comprehensive recall strategies including scope, depth, methods of contact, and timelines. •Serve as the primary point of contact with the FDA Recall Coordinator, global competent authorities, and regulatory agencies. •Ensure timely submission of recall notifications, updates, and status reports to FDA and international regulatory bodies. •Maintain full compliance with 21 CFR Part 7, 21 CFR Part 806, and ISO 13485 standards related to nonconformance, corrective action, and post-market surveillance. •Partner cross-functionally with QA, RA, Legal, Supply Chain, Sales, Customer Service, and Field Service to coordinate recall activities and minimize disruption to customers and patients. Qualifications: •Master's degree in Regulatory Affairs or a related field. •Certification in Quality Management (e.g., Certified Manager of Quality/Organizational Excellence) or Regulatory Affairs (e.g., RAC from the Regulatory Affairs Professionals Society). •Direct hands-on experience in manufacturing or development of a medical device. •Knowledge of international product registration support. •Regulatory Knowledge: Deep understanding of medical device regulations including FDA 21 CFR Part 820 (QSR), Part 7, 806, 810, and other applicable global regulations related to recall management. •General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!