Global Clinical Regulatory Support Specialist

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🔥 0 minutes ago

⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $108.5k - $135.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

💝 Customer Support

👻 Ghost score 0%

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Terumo Blood and Cell Technologies

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1964

🏥 Healthcare

🍽️ Food & Beverage

💼 Consulting

Healthcare • Food & Beverage • Consulting

Terumo Blood and Cell Technologies is a global leader in blood management solutions, specializing in the collection, processing, and delivery of blood and cell-based therapies. The company offers a range of innovative products and services, including automated blood collection systems, pathogen reduction technologies, and therapeutic apheresis solutions. With a strong commitment to improving patient care, Terumo Blood and Cell Technologies provides critical support to hospitals, healthcare providers, and biotechnology companies, ensuring the highest standards of service and safety in blood and cell therapy.

📋 Description

• Write Clinical Evaluation Plans and Reports (CEPs/CERs) and Post-market Clinical Follow-up (PMCF) Plans and Reports • Collect, appraise and extract safety and performance data • Compile and author new and scheduled Systematic Literature Reviews, Clinical Evaluation and PMCF documentation • Lead CER and PMCF development by coordinating Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, research, marketing, engineering and information specialists • Collaborate on systematic literature searches for TBCT products, equivalent, comparator and competitor products • Review published literature for applicable safety and performance evidence • Develop literature search strategies and facilitate SLRs • Compile risk management, labeling, post-market surveillance, verification, validation, preclinical and clinical data • Manage document reviews, reconcile comments and oversee final approval • Provide input on risk management, clinical research and literature evidence for product development • Conduct proactive literature reviews to identify complaints and safety concerns • Represent the functional group in audits and contribute to global regulatory submissions or responses • Monitor clinical evaluation and PMCF regulatory requirements • Develop policies and procedures • Guide contractors in document development and updates • Disseminate findings from clinical evaluation and proactive literature reviews • Develop SLR, Clinical Evaluation and PMCF deliverables, timelines and draft reviews • Ensure compliance with applicable laws, regulations, standards and company procedures

🎯 Requirements

• Graduate degree (e.g. MS, PhD) in a scientific, biological, medical science or regulatory discipline, or equivalent education and experience sufficient to perform the essential functions • 5 years of experience • Knowledge of research methodology and information management • Experience with relevant databases • Knowledge of regulatory requirements • Training and experience in medical writing, systematic review and clinical data appraisal • Clinical evaluation reporting experience in academic, medical device or pharmaceutical industry clinical/regulatory roles, or device development experience • Experience and understanding of clinical research and regulatory guidelines • Knowledge of CE Marking, IDE, PMA, 510(k), post-market/post-approval processes, GCP procedures and legal compliance • Proficiency with Microsoft Office, Excel, Word and PowerPoint • Demonstrated writing and critique capability for clinical and regulatory documentation • Program/project management skills • Ability to develop and implement global policies and procedures • Ability to analyze information from multiple internal and external sources • Ability to learn general writing and presentation software

🏖️ Benefits

• Multiple group medical, dental and vision plans • Robust wellness program • Life insurance and disability coverage • Group accident, hospital indemnity, critical illness and pet insurance • 401(k) plan with matching contribution • Vacation and sick time programs • Recognition, work-life and well-being programs • Equal opportunity employment • Reasonable accommodations for individuals with disabilities • Tobacco-free and drug-free workplace