Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Responsibilities:

• Required Skill 1: Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation
• Required Skill 2: 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)
• Required Skill 3: Ability to Problem Solve Independently & with Others - Highly Skilled
• Required Skill 4: Execution / Results / Process Improvement - Highly Skilled
• Required Skill 5: Cross Functional Relationships and communication skills - Highly Skilled
• Bachelor of Science
• 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
• Biomedical engineer or RN preferred
• Individual setting, Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)
• No
• None
• Medical Device Risk Management
• Medical Device complaint handling
• Medical Device literature searches/reviews
• The Pharmacovigilance and Patient Safety (PPS) organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of Client products to protect patients worldwide.
• 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.

Requirements:

• 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.
• 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