Hiring: Global Clinical Regulatory Support Specialist Company: Terumo Blood and Cell Technologies Location: Lakewood, CO Job Posted Time: 2026-09-12 13:44:15 Employment Type: Remote Target Skills & Keywords : GCP, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Project Management, Quality Assurance, Risk Management About the job Experience: •Qualified individuals have 5 yrs experience and should possess knowledge of the following: research methodology; information management; experience with relevant databases; regulatory requirements; training and experience in medical writing; systematic review; and clinical data appraisal. •Clinical evaluation reporting experience in academic or the medical device/pharmaceutical industry in clinical, or regulatory roles, or device development experience in medical device/pharmaceutical industry. •The Specialist has experience and understanding of clinical research and regulatory guidelines. Required Skills: •Partner cross-functionally with the information specialist to conduct systematic literature searches on TBCT products and product families, and identified equivalent, comparator and competitor products •Review and Appraise the published literature to identify articles applicable to the safety and performance of TBCT products. •Author new and scheduled SLRs, CER and PMCF documents for TBCT products, according to business and research priorities •Manage document reviews, reconcile major review comments and concerns, and manage finalization and approval of the SLR, Clinical Evaluation and PMCF documents. •Partner cross-functionally with relevant cross-functional teams to provide input on risk management deliverables, clinical research and literature evidence for product development process needs •Manage ongoing proactive literature review to identify complaints or safety concerns for a specific product portfolio •Represent functional group for audits and contribute to global regulatory body submissions or responses •Remain current in Clinical Evaluation and PMCF regulatory requirements for all applicable countries Qualifications: •A graduate degree (e.g. MS, PhD) in a scientific, biological or medical science discipline and/or regulatory discipline or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. •Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. Compensation: •Flexible work environment (work from home / hybrid options) •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!