UDI
UDI (Unique Device Identification) is a standardized system for marking and identifying medical devices throughout their distribution and use. Think of it like a specialized barcode system for medical devices that helps track products from factory to patient. Companies use UDI to ensure safety, manage recalls if needed, and follow FDA rules. This tracking system has become a must-have in medical device companies since the FDA made it required. When people mention UDI in their resumes, they're usually talking about their experience with implementing or managing these identification systems in medical device manufacturing or healthcare settings.
Examples in Resumes
Led implementation of UDI compliance program across 5 product lines
Managed UDI data submission to FDA's GUDID database for 200+ medical devices
Developed standard operating procedures for UDI labeling and tracking
Typical job title: "UDI Specialists"
Also try searching for:
Where to Find UDI Specialists
Professional Organizations
Online Resources
Example Interview Questions
Senior Level Questions
Q: How would you manage a UDI implementation project for a company with multiple product lines?
Expected Answer: Look for answers that show experience in project management, understanding of FDA timelines, and ability to coordinate between different departments (manufacturing, quality, IT). They should mention risk management and training plans.
Q: What strategies would you use to ensure ongoing UDI compliance?
Expected Answer: Strong answers should include creating standard procedures, regular audits, staff training programs, and systems for monitoring regulatory updates from the FDA.
Mid Level Questions
Q: What are the key components of a UDI label?
Expected Answer: Should mention Device Identifier (DI) and Production Identifier (PI), explain basic labeling requirements, and show understanding of different date formats and product information needed.
Q: How do you submit device information to the GUDID database?
Expected Answer: Should demonstrate familiarity with FDA's Global Unique Device Identification Database submission process and common submission methods.
Junior Level Questions
Q: What is the purpose of UDI system?
Expected Answer: Should explain basic concepts of medical device tracking, patient safety benefits, and why the FDA requires this system.
Q: What are the main differences between DI and PI in UDI?
Expected Answer: Should be able to explain that Device Identifier is the fixed part identifying the device model, while Production Identifier includes variable information like lot number and expiration date.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of UDI requirements
- Familiarity with medical device labeling
- Knowledge of FDA regulations
- Basic database management
Mid (2-5 years)
- GUDID data submission experience
- UDI implementation experience
- Quality system documentation
- Team coordination skills
Senior (5+ years)
- Project management for UDI implementation
- Regulatory compliance strategy
- Cross-functional team leadership
- Audit management experience
Red Flags to Watch For
- No knowledge of FDA medical device regulations
- Lack of experience with quality management systems
- No understanding of medical device labeling requirements
- Unable to explain basic UDI components
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