GUDID
GUDID (Global Unique Device Identification Database) is a key system in medical device manufacturing that helps track and identify medical devices. Think of it like a giant digital library that stores important information about every medical device. When companies make medical devices, they need to enter product details into this database to comply with FDA requirements. This helps hospitals, healthcare providers, and regulators easily find information about devices, track safety issues, and manage recalls if needed. It's similar to having a universal product code (UPC) system, but specifically for medical devices.
Examples in Resumes
Managed GUDID submissions for 200+ Class II medical devices
Led team responsible for maintaining compliance with GUDID requirements
Streamlined GUDID data entry process, reducing submission time by 40%
Typical job title: "GUDID Specialists"
Also try searching for:
Where to Find GUDID Specialists
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a large-scale GUDID submission project for multiple product lines?
Expected Answer: Should discuss project management skills, prioritization strategies, team coordination, and quality control measures. Should mention experience with handling complex submissions and troubleshooting submission errors.
Q: How do you stay current with FDA UDI requirements and ensure compliance?
Expected Answer: Should demonstrate knowledge of regulatory monitoring processes, mention specific FDA resources they follow, and explain how they implement updates to maintain compliance.
Mid Level Questions
Q: What information is required for a GUDID submission?
Expected Answer: Should be able to list key device identification elements, packaging information, and regulatory details required for submissions. Should understand different requirements for various device classes.
Q: How do you handle GUDID data maintenance and updates?
Expected Answer: Should explain processes for keeping device information current, handling product changes, and ensuring accuracy of submissions over time.
Junior Level Questions
Q: What is GUDID and why is it important?
Expected Answer: Should explain that GUDID is the FDA's database for medical device identification and its role in device tracking, safety, and recalls.
Q: What tools do you use for GUDID submissions?
Expected Answer: Should be familiar with basic submission methods like FDA's electronic submission system and understand the importance of accurate data entry.
Experience Level Indicators
Junior (0-2 years)
- Basic GUDID data entry
- Understanding of UDI requirements
- Familiarity with FDA submission systems
- Basic medical device documentation
Mid (2-5 years)
- Managing multiple GUDID submissions
- Problem-solving submission errors
- Understanding regulatory requirements
- Quality control procedures
Senior (5+ years)
- Strategic compliance planning
- Team leadership and training
- Complex submission management
- Regulatory interpretation and implementation
Red Flags to Watch For
- No knowledge of basic FDA medical device regulations
- Lack of attention to detail in data entry
- No experience with regulatory documentation
- Unable to explain UDI system basics
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