IVDR
IVDR (In Vitro Diagnostic Regulation) is a set of rules in Europe that companies must follow when making medical tests and diagnostic products - things like blood tests, pregnancy tests, or diabetes monitoring equipment. It replaced older rules in 2022 to make medical testing products safer and more reliable. When you see IVDR mentioned in a resume, it means the person has experience making sure these medical testing products meet European safety standards. Think of it like a strict recipe book that companies must follow to ensure their medical tests are safe and accurate for patients.
Examples in Resumes
Led team compliance efforts for IVDR transition of 5 diagnostic products
Managed quality documentation updates to meet IVDR requirements
Successfully prepared company's diagnostic portfolio for IVDR certification
Typical job title: "IVDR Compliance Specialists"
Also try searching for:
Where to Find IVDR Compliance Specialists
Professional Organizations
Online Communities
Job Boards
Example Interview Questions
Senior Level Questions
Q: How would you manage the transition from the old IVD Directive to IVDR for a large product portfolio?
Expected Answer: Should explain the process of gap analysis, timeline planning, resource allocation, and risk management. Should mention working with different departments and managing documentation updates.
Q: What strategies would you use to ensure ongoing IVDR compliance in a medical device company?
Expected Answer: Should discuss quality management systems, internal audits, staff training programs, and maintaining relationships with notified bodies. Should mention monitoring regulatory updates.
Mid Level Questions
Q: What are the main differences between the old IVD Directive and IVDR?
Expected Answer: Should explain key changes like new risk classifications, increased documentation requirements, and stricter clinical evidence needs in simple terms.
Q: How do you ensure proper technical documentation for IVDR compliance?
Expected Answer: Should describe the basic structure of technical files, importance of clinical evidence, and process for keeping documentation up to date.
Junior Level Questions
Q: What is IVDR and why is it important?
Expected Answer: Should explain that IVDR is European regulation for medical testing products, aimed at ensuring safety and performance of diagnostic tests.
Q: What types of products need to comply with IVDR?
Expected Answer: Should list common examples like blood tests, pregnancy tests, genetic tests, and lab diagnostic equipment.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of IVDR requirements
- Document control and organization
- Quality management system basics
- Supporting compliance activities
Mid (2-5 years)
- Managing technical documentation
- Risk management activities
- Internal auditing
- Interaction with notified bodies
Senior (5+ years)
- Strategic compliance planning
- Team leadership and training
- Regulatory strategy development
- Managing multiple product certifications
Red Flags to Watch For
- No knowledge of basic quality management systems
- Unfamiliarity with medical device regulations beyond IVDR
- Lack of experience with technical documentation
- Poor understanding of risk management principles
Related Terms
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