Senior Global Recall Specialist

About the Role

At Terumo Blood and Cell Technologies, our 8,000+ global associates impact the lives of patients around the world by making medical devices and related products used to collect, separate, manufacture, and process various components of blood and cells. This role plays a critical part in leading and managing all product recall, field action, and market recall activities in compliance with FDA 21 CFR Part 7, 21 CFR Part 806, ISO 13485:2016, and other applicable international regulatory requirements. The Senior Global Recall Specialist serves as the central liaison between the company, regulatory authorities, and global functional teams to ensure swift, compliant, and effective execution of both voluntary and mandatory product recalls.

Responsibilities

• 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.
• Collaborate with QA, RA, Legal, Supply Chain, Sales, Customer Service, and Field Service to coordinate recall activities and minimize disruption to customers and patients.
• Lead cross-functional recall teams to ensure rapid and aligned decision-making during recall events.
• Maintain detailed and audit-ready documentation of all recall activities, including risk assessments, root cause analysis, CAPA, communications, response tracking, and effectiveness checks.
• Develop, maintain, and conduct recall training programs and periodic mock recall drills to ensure global team preparedness.
• Lead and manage a recall workforce or temporary staffing, including requisitioning, work assignment, performance monitoring, and timecard approval.
• Track key recall performance indicators (e.g., time to initiation, time to closure, response rate, effectiveness).
• Analyze trends in product complaints, deviations, and quality events to identify and mitigate potential recall risks.
• Propose and implement process improvements to enhance recall efficiency and reduce recurrence.

Requirements

• Bachelor's Degree, preferably in a science-related field, Quality Assurance, Regulatory Affairs, Engineering, or a related field.
• 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.

Preferred 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.
• 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.

Skills

• Proficiency in Microsoft applications, including Excel, Word, and PowerPoint.
• Experience with recall management software (e.g., WindChill, SAP) is a plus.
• Experience with data analysis for identifying trends and metric generation and reporting.
• Excellent written and verbal communication skills with the ability to effectively communicate at multiple levels within the organization and with external stakeholders.
• Strong organizational skills, attention to detail, and the ability to manage multiple tasks and prioritize work to meet deadlines in a fast-paced environment.
• Strong analytical and problem-solving skills, with the ability to exercise sound judgment.
• Ability to work independently and as part of a team, fostering a collaborative environment.
• Strong sense of responsibility, self-motivation, and the ability to function effectively under pressure to meet regulatory reporting requirements.

Schedule

• Lakewood, Colorado - Onsite (hybrid).
• Must be available to respond to critical recall events beyond regular business hours if needed.
• May require domestic or international travel based on business needs. Approximately 10%.

Physical Requirements

• General labor environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity.
• Occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

Pay

Target Pay Range: $108,300.00 to $135,400.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.

Target Bonus on Base: 7.0%

Benefits

• Competitive total reward offerings including compensation, benefits, and recognition programs.
• Multiple group medical, dental, and vision plans.
• Robust wellness program.
• Life insurance and disability coverages.
• Voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance, and more.
• 401(k) plan with a matching contribution.
• Vacation and sick time programs.