Manager, Quality - Adverse Event Reporting and Field Action

Terumo BCT, Inc. • Denver, CO

5d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Nursing, or related field, and/or equivalent combination of education and experience.
• Minimum 7 years of experience in medical device post-market surveillance/vigilance, complaint handling, and/or regulatory compliance, including hands-on adverse event reporting responsibilities.
• Minimum 3 years of experience leading field actions (recalls/corrections/removals) and cross-functional response teams.
• Strong working knowledge of global vigilance and reporting requirements (e.g., FDA MDR 21 CFR Part 803, EU MDR vigilance, ISO 13485 complaint handling expectations, and applicable local-market requirements).
• Demonstrated ability to interpret regulations and apply them to complex scenarios, strong documentation and technical writing skills.
• Experience partnering with Quality/Risk Management and CAPA processes; ability to ensure traceability across complaint, investigation, risk, and CAPA records.
• Proficiency with eQMS/complaint handling systems and Microsoft Office.
• Strong communication, facilitation, and stakeholder management skills, including comfort interacting with regulatory authorities.

Nice To Haves

• Master’s degree or advanced clinical degree strongly preferred.
• People management experience in a global vigilance or regulatory compliance organization.
• Experience with blood management, apheresis, transfusion medicine, extracorporeal/sterile fluid path devices, or capital equipment with software and disposables.
• Experience preparing health hazard evaluations, recall strategy documentation, and effectiveness checks across multiple regions.
• Experience supporting FDA inspections and/or EU Notified Body audits related to PMS/vigilance and field actions.
• Regulatory judgment and attention to detail
• Risk-based decision making and sound escalation
• Program/project management; ability to manage multiple priorities and deadlines
• Clear, concise technical writing and documentation discipline
• Influence without authority and cross-functional leadership
• Data analysis, trending, and problem solving
• Continuous improvement mindset
• Certifications such as ASQ (CQA/CQE), RAC, or equivalent.

Responsibilities

• 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.
• People leadership (if applicable): Recruit, coach, and develop team members; set objectives, conduct performance management, and foster a culture of compliance and continuous improvement.
• Perform additional related duties as assigned.

Benefits

• multiple group medical, dental and vision plans
• a robust wellness program
• life insurance and disability coverages
• a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more
• a 401(k) plan with a matching contribution
• vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager