Manager, Quality - Adverse Event Reporting and Field Action
22 days ago
Lakewood
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., • 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., • Bachelor's degree in Engineering, Life Sciences, Nursing, or related field, and/or equivalent combination of education and experience., • Master's degree or advanced clinical degree strongly preferred. 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., • 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 Certificates, Licenses, Registration Certifications such as ASQ (CQA/CQE), RAC, or equivalent. LOCATION • Lakewood, Colorado - Open to candidates willing to relocate to the area., • Office-based or hybrid work environment depending on business needs. TRAVEL/HOURS • Travel required (up to 20%)., • Domestic and international travel up to ~10-20% (may vary), including site visits, audits, and regulatory meetings., • May require occasional off-hours availability to support urgent safety issues and time-sensitive regulatory reporting. PHYSICAL REQUIREMENTS • Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds., • The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job., • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range:$123,100.00to$153,900.00 -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:10.0% We anticipate this requisition will be open for a minimum of five days, from April 6, 2026. We encourage your prompt application. At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan., • In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue., • We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo., • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries., • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare., • Respect - Appreciative of others, • Integrity - Guided by our mission, • Care - Empathetic to patients, • Quality - Committed to excellence, • Creativity - Striving for innovation, • We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
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