Recruiter's Glossary

Examples: Notified Body • Environmental Monitoring • ISO Class 7

EUDAMED

Term from Medical Device Manufacturing industry explained for recruiters

EUDAMED is the European Union's database for medical devices. Think of it as a central hub where companies register their medical products before selling them in Europe. It's like a digital passport system for medical devices, ensuring they meet all European safety requirements. Companies use this system to track their products, report safety issues, and maintain compliance with European regulations. When you see EUDAMED mentioned in a resume, it usually means the person has experience with European medical device regulations and compliance.

Examples in Resumes

Managed EUDAMED submissions for Class III medical devices in European market

Led team responsible for EUDAMED device registration and compliance

Coordinated regulatory submissions through EUDAMED database for new product launches

Typical job title: "Medical Device Regulatory Affairs Specialists"

Also try searching for:

Regulatory Affairs Specialist Medical Device Compliance Manager EU MDR Specialist Regulatory Submissions Specialist Medical Device Quality Specialist Medical Device Registration Specialist

Where to Find Medical Device Regulatory Affairs Specialists

Professional Organizations

Online Resources

Job Boards

Example Interview Questions

Senior Level Questions

Q: How would you manage a team handling multiple EUDAMED submissions across different device classes?

Expected Answer: Look for answers showing experience in project management, understanding of different device risk classifications, and ability to prioritize submissions based on regulatory deadlines and business needs.

Q: What strategies would you implement to ensure successful EUDAMED compliance across an organization?

Expected Answer: Candidate should discuss creating standard procedures, training programs, internal audits, and maintaining documentation systems.

Mid Level Questions

Q: What are the main modules of EUDAMED and their purposes?

Expected Answer: Should be able to explain the basic modules like device registration, certificate management, and vigilance reporting in simple terms.

Q: How do you handle EUDAMED submission errors or technical issues?

Expected Answer: Should demonstrate problem-solving skills and knowledge of troubleshooting procedures, including working with support teams and documentation.

Junior Level Questions

Q: What is EUDAMED and why is it important?

Expected Answer: Should explain that it's the EU's medical device database used for registration and tracking, emphasizing its role in product safety and compliance.

Q: What basic information is needed for a EUDAMED device registration?

Expected Answer: Should know basic requirements like manufacturer details, device classification, and basic product information.