Recruiter's Glossary

Examples: IVDR • PMA • European Pharmacopoeia

Notified Body

Term from Medical Device Manufacturing industry explained for recruiters

A Notified Body is an organization that checks if medical devices are safe and work properly before they can be sold in Europe. Think of them like independent inspectors who give their seal of approval. Companies need this approval to sell their medical products in European countries. These organizations review product documentation, inspect manufacturing facilities, and test devices to make sure they meet all European safety rules. They're similar to how the FDA works in the United States, but Notified Bodies are private organizations approved by European governments rather than being government agencies themselves.

Examples in Resumes

Managed product submissions to Notified Body for CE marking certification

Coordinated with Notified Body auditors during annual quality system inspections

Led remediation efforts following Notified Body audit findings

Typical job title: "Regulatory Affairs Specialists"

Also try searching for:

Quality Assurance Manager Regulatory Compliance Manager Medical Device Quality Engineer Regulatory Affairs Manager Quality Systems Specialist Medical Device Compliance Specialist

Where to Find Regulatory Affairs Specialists

Professional Organizations

Job Boards

Professional Networks

Example Interview Questions

Senior Level Questions

Q: How would you manage a critical finding from a Notified Body audit?

Expected Answer: A senior candidate should explain the process of developing corrective action plans, managing communications with the Notified Body, implementing solutions, and preventing similar issues in the future. They should demonstrate experience with risk management and change control processes.

Q: What strategies would you use to prepare a company for a Notified Body audit?

Expected Answer: The answer should cover conducting internal audits, reviewing quality system documentation, training staff, preparing documentation packages, and having a clear communication plan. They should also mention experience with mock audits and gap assessments.

Mid Level Questions

Q: What documentation is typically required for a Notified Body submission?

Expected Answer: Should be able to list key documents like technical files, clinical data, risk management files, and quality system documentation. Should understand the basic review process and timelines.

Q: How do you ensure ongoing compliance with Notified Body requirements?

Expected Answer: Should discuss regular internal audits, document control, change management procedures, and staying updated with regulatory changes. Should mention the importance of maintaining communication with the Notified Body.

Junior Level Questions

Q: What is the role of a Notified Body in medical device manufacturing?

Expected Answer: Should explain that Notified Bodies are organizations that assess if medical devices meet European safety requirements, perform audits, and issue certifications needed to sell products in Europe.

Q: What is CE marking and how does it relate to Notified Bodies?

Expected Answer: Should explain that CE marking is required to sell medical devices in Europe, and Notified Bodies are the organizations that verify products meet the requirements to receive this marking.