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.

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, proper product safety usage as needed and complaint assessments
• 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.

Experience/Skills:

• Bachelor of Science
• Biomedical engineer or RN preferred
• Medical Device Risk Management experience preferred
• Medical Device complaint handling experience preferred
• Medical Device literature searches/reviews experience preferred
• 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
• 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)
• Ability to Problem Solve Independently & with Others - Highly Skilled
• Execution / Results / Process Improvement - Highly Skilled
• Cross Functional Relationships and communication skills - Highly Skilled

Job Types: Full-time, Contract

Pay: Up to $54.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• medical device quality: 4 years (Preferred)
• safety analyst: 5 years (Preferred)

Work Location: Remote

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