510(k)
A 510(k) is a required approval process from the Food and Drug Administration (FDA) that medical device companies must complete before they can sell most medical devices in the United States. Think of it as a permission slip that proves a new medical device is safe and works similarly to devices already on the market. When you see this term on a resume, it usually means the person has experience with preparing these submissions or managing the approval process, which is a valuable skill in medical device companies.
Examples in Resumes
Led team in successful 510(k) submission for new cardiac monitoring device
Prepared and submitted 5 510(k) clearances with 100% approval rate
Managed documentation and testing requirements for 510(k) submissions
Typical job title: "Regulatory Affairs Specialists"
Also try searching for:
Where to Find Regulatory Affairs Specialists
Professional Associations
Online Resources
Job Boards
Example Interview Questions
Senior Level Questions
Q: How would you handle a situation where the FDA requests additional information for a 510(k) submission?
Expected Answer: A senior candidate should explain the process of reviewing FDA requests, coordinating with internal teams to gather data, and managing timelines to respond effectively while maintaining compliance.
Q: Describe your experience with developing regulatory strategies for new medical devices.
Expected Answer: Should demonstrate experience in assessing products, determining the appropriate regulatory pathway, and creating comprehensive submission plans that align with business goals.
Mid Level Questions
Q: What are the key components of a 510(k) submission?
Expected Answer: Should be able to list main sections like device description, substantial equivalence, testing data, and explain the importance of each component in simple terms.
Q: How do you determine if a device modification requires a new 510(k)?
Expected Answer: Should explain the basic decision-making process for when changes in design, materials, or intended use might require a new submission.
Junior Level Questions
Q: What is the purpose of a 510(k) submission?
Expected Answer: Should explain that it's the FDA's process to ensure new medical devices are safe and effective by comparing them to already approved devices.
Q: What's the difference between a 510(k) and a PMA?
Expected Answer: Should be able to explain that 510(k) is for devices similar to existing ones, while PMA is for new and high-risk devices.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FDA regulations
- Assisting with 510(k) documentation
- Document control and organization
- Basic quality system knowledge
Mid (2-5 years)
- Managing complete 510(k) submissions
- Interaction with FDA reviewers
- Testing requirement planning
- Technical writing for submissions
Senior (5+ years)
- Strategic regulatory planning
- Multiple successful submissions
- Team leadership and training
- Complex submission management
Red Flags to Watch For
- No knowledge of basic FDA regulations
- Unfamiliarity with medical device quality systems
- Poor attention to detail in documentation
- No experience with regulatory submissions
- Lack of understanding of medical device classification
Related Terms
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