Recruiter's Glossary

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Technical File

Term from Medical Device Manufacturing industry explained for recruiters

A Technical File is a collection of important documents that proves a medical device is safe and works as intended. Think of it as a product's complete life story - from initial design to final testing. Medical device companies must create and maintain these files to legally sell their products in different countries, especially in Europe. It's similar to a detailed recipe book that shows regulators exactly how a medical device is made, tested, and monitored for safety. When you see this term in resumes, it usually means the person has experience with medical device documentation and regulatory requirements.

Examples in Resumes

Managed and updated Technical File documentation for Class II medical devices

Led the creation and maintenance of Technical Files and Device Master Records for new product launches

Collaborated with R&D team to ensure Technical File compliance with EU MDR requirements

Typical job title: "Technical Documentation Specialists"

Also try searching for:

Regulatory Affairs Specialist Quality Assurance Specialist Documentation Specialist Medical Device Documentation Manager Technical Writer Regulatory Compliance Specialist Quality Systems Specialist

Where to Find Technical Documentation Specialists

Professional Associations

Online Communities

Job Boards

Example Interview Questions

Senior Level Questions

Q: How would you manage a Technical File for a product being launched in multiple international markets?

Expected Answer: Should explain how they would coordinate with different teams, understand varying regulatory requirements by region, and maintain documentation that satisfies multiple market needs simultaneously. Should mention experience with different international standards and submission processes.

Q: What experience do you have with Technical File remediation projects?

Expected Answer: Should describe experience in reviewing existing files, identifying gaps, creating action plans, and updating documentation to meet current regulations. Should mention stakeholder management and timeline planning.

Mid Level Questions

Q: What are the essential components of a Technical File?

Expected Answer: Should list main sections like device description, risk management, clinical evaluation, labeling, and verification testing. Should explain why each component is important for regulatory compliance.

Q: How do you ensure Technical File documentation stays current?

Expected Answer: Should discuss document control procedures, change management processes, and regular review cycles. Should mention collaboration with R&D and Quality teams.

Junior Level Questions

Q: What is the purpose of a Technical File?

Expected Answer: Should explain that it's the main documentation package proving a medical device's safety and performance, required for regulatory approval and market access.

Q: How do you organize documents within a Technical File?

Expected Answer: Should describe basic document management principles, filing systems, and the importance of maintaining proper document versions and approvals.