Adverse Event Reporting Specialist (Larne Millbrook, GB) @ Terumo BCT, Inc.

Adverse Event Reporting & Global Vigilance Specialist (26_35) At Terumo BCT , a global leader in blood management, blood safety, therapeutic apheresis, cell therapy, and cell collection technologies, we are dedicated to improving and extending lives through innovation and excellence. We are pleased to offer an exciting opportunity for an Adverse Event Reporting & Global Vigilance Specialist to join our team. In this key role, the successful candidate will provide quality and regulatory support for adverse event reporting (AER), medical device reporting (MDR), and global vigilance activities.

This position supports complaint intake review, reportability evaluation, regulatory submission preparation, follow-up coordination, timeline tracking, metrics, and maintenance of complete, accurate, traceable, and audit-ready AER/MDR-vigilance records in accordance with applicable procedures, work instructions, regulatory expectations, and business priorities.

Key Responsibilities

• Reviews complaints, service records, customer communications, returned product information, and other quality records to identify potentially reportable information for adverse events or vigilance events requiring further assessment or submissions.
• Performs and/or supports reportability evaluations using approved procedures, regulatory criteria, risk management documentation, clinical/technical information, product information, and available complaint investigation details.
• Prepares, submits, and tracks initial, supplemental, follow-up, and final MDR/vigilance reports to applicable regulatory authorities within required timelines, as assigned and in alignment with approved processes.
• Maintains accurate AER/MDR-vigilance documentation, including reportability rationale, submission records, supporting evidence, submission confirmations, follow-up attempts, regulatory correspondence, and closure documentation.
• Coordinates other stakeholders to obtain additional information needed to support reportability determinations and regulatory submissions.
• Supports intake screening, keyword searches, AI-assisted or system-based review activities, and complaint queue monitoring to help prioritize potentially reportable events and reduce risk of missed or delayed reporting.
• Requests, tracks, and documents follow-up information from internal stakeholders, customers, regions, or complaint investigators, and escalates missing or conflicting information that may impact reporting timelines or submission quality.
• Monitors AER/MDR-vigilance timelines, aging, due dates, late or at-risk records, pending information, open tasks, and submission status; escalates risks, delays, or potential compliance concerns to management in a timely manner Supports AER/MDR review meetings or committees by preparing agendas, compiling records for review, documenting decisions and action items, tracking owners and due dates, and maintaining meeting minutes or related evidence.
• Assists with monthly metrics, dashboards, trend summaries, late-report reviews, reportability volumes, submission status, product line summaries, region summaries, and other management reporting related to AER/MDR-vigilance performance.
• Supports audit, inspection, CAPA, nonconformance, remediation, and continuous-improvement activities related to adverse event reporting, complaint reportability, regulatory submissions, documentation quality, and process effectiveness.
• Maintains awareness of applicable medical device reporting and vigilance requirements, internal procedures, work instructions, process changes, and training expectations relevant to assigned responsibilities.
• May assist with urgent or time-sensitive AER/MDR-vigilance activities outside normal business hours based on business need and management direction.
• Performs duties of the Senior Adverse Event Reporting & Global Vigilance Specialist as needed.
• Performs other duties as assigned to support adverse event reporting (AER), Medical Device Reporting (MDR), and global vigilance activities, audit readiness, compliance, and continuous improvement objectives.
• Minimum Qualifications & Experience Education Bachelor’s degree in Quality, Regulatory Affairs, Life Sciences, Nursing, Clinical Sciences, Engineering, Business, or a related field preferred.
• Equivalent combination of education, training, and relevant experience sufficient to successfully perform the essential functions of the job may be considered.
• Experience Minimum 3-5 years of experience in Quality, Regulatory Affairs, complaint handling, adverse event reporting, medical device reporting, vigilance, post-market surveillance, clinical safety, customer support, or another regulated medical device or life sciences environment.
• Experience supporting reportability assessments, MDR/vigilance submissions, complaint intake review, event narrative preparation, follow-up coordination, regulatory documentation, audit-ready quality records, or cross-functional post-market quality processes preferred.
• Skills Working knowledge of quality systems and regulated documentation practices, with the ability to maintain complete, accurate, traceable, and audit-ready AER/MDR-vigilance records.
• Basic understanding of medical device adverse event reporting, MDR, vigilance, complaint handling, health hazard or safety assessment concepts, post-market surveillance, and global regulatory reporting expectations preferred.
• Ability to review complaint information, issue descriptions, quality questions, investigation details, risk documentation, and follow-up evidence to support reportability evaluation and regulatory submission activities.
• Ability to prepare clear event narratives, reportability rationales, follow-up requests, committee summaries, status updates, submission support documentation, and audit/inspection responses.
• Strong attention to detail with the ability to track multiple records, reporting timelines, due dates, owner actions, customer or regional follow-ups, submission status, and documentation gaps.
• Strong written and verbal communication skills, including the ability to communicate with cross-functional and global stakeholders and escalate risks, delays, conflicting information, or potential compliance concerns appropriately.
• Strong organizational skills, prioritization skills, and ability to support time-sensitive reporting activities in a fast-paced regulated environment.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, Teams, SharePoint, and tracking tools; experience with eQMS, complaint management systems, electronic MDR/vigilance submission tools, ERP, Windchill, SAP, or data reporting systems preferred.
• Demonstrated ability to follow procedures and work instructions, identify documentation gaps, support problem solving, and contribute to continuous improvement of AER/MDR-vigilance screening, reporting, monitoring, and closure processes.
• Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

Additional Information May require domestic or international travel based on business needs. If you're ready to make a significant impact in a dynamic and collaborative environment, we invite you to apply for this exciting opportunity. Please submit your CV via our Terumo BCT career’s portal mySource before the closing date of 5pm Wednesday, 04th November 2026. You must clearly demonstrate on your CV / application how you meet the required criteria as failure to do so may result in you not being shortlisted. Join us in driving progress and supporting patients locally and across the globe every day by Contributing to Society Through Healthcare!