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


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