Job Description: The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients. Responsibilities: Assisting with ongoing continuous improvement projects spanning across departmental needs. Responsible for individual and periodic medical device safety reporting. Responsible for PI site notifications. Providing support for training and automation efforts. Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed. Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products. Biomedical engineer or RN Required. Requirements: Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing. Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential cases. Knowledge of Research & Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting). Clinical Trial Experience. Clinical Trial Device Experience. Knowledge of electronic databases (e.g., Rave EDC, Veeva EDC, Microsoft Office including Excel, Oracle, Veeva, Salesforce Applications and other database tools.) Ability to effectively interact with and influence others without direct reporting relationships. Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs. Ability to Meet Challenging Milestones with results orientation - Skilled. Strategic Decision Making and Negotiation - Skilled. Facilitating Change and managing conflicts - Skilled. Ability to Problem Solve Independently & with Others - Highly Skilled. Business Organization & Industry Awareness - Highly Skilled. Cross Functional Relationships and communication skills - Highly Skilled. Execution / Results / Process Improvement - Highly Skilled. Background / Required and Preferred Education Level. RN Required (Active licensure). Katalyst Healthcares and Life Sciences
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