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.
Activities performed under this team:
Assisting with ongoing continuous improvement projects spanning across departmental needs
Providing support for training and automation efforts
Identify regional label variances and build tool to capture info for priority products and main competitors
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.
Participate in root-cause investigations into device failures and human factors-related use errors.
Qualifications Desired Skills:
Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation
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)
Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, 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
Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) *CO candidates may not be considered