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Feb 2025

How to answer this Ethics and Integrity interview question about Regulatory Compliance for Senior-Level Biomedical Engineer?

How do you ensure compliance with medical device regulations during the product development process?

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Biomedical Engineer

Ethics and Integrity

Asked at

Johnson & Johnson

Difficulty :

Hard

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Explanation

This question assesses your knowledge of regulatory standards like FDA and ISO and how you incorporate them into your work. Recruiters want to see your ability to ensure compliance while meeting development goals. A strong answer includes specific regulations, processes, and examples of maintaining compliance. Avoid vague responses or failing to mention key regulatory frameworks.

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Answer Example

I ensure compliance by integrating regulatory requirements, such as FDA 21 CFR Part 820 and ISO 13485, into every stage of the product lifecycle. For instance, while developing a surgical tool, I collaborated with the QA team to document design inputs and outputs, conducted design verifications, and prepared the device for successful FDA approval. This streamlined the certification process and reduced time-to-market by 20%.

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