New 
Medical Device SafetyAnalyst
 Spectraforce Technologies | |
 United States, California, South San Francisco | |
 Jan 17, 2025 | |
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Job Title : Medical Device Safety Analyst
Location:100% Remote Duration: 12 Months 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 PSEQ 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. Experience & Skills: 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., TrackWise, Business Objects, Oracle, Veeva, Argus, EDC Rave, Veeva EDC 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 Core Essential Skills: 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: Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing RN Required | |