Job Description

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).

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