As a biomedical engineer, you’ll be responsible for creating medical devices that are safe and effective for their intended uses. To do that, you’ll need to be familiar with the regulatory requirements and guidelines that govern the medical device industry. The interviewer is asking this question to determine if you have a good understanding of the regulations that are applicable to the devices you’ll be creating.
How to Answer:
If you have experience with regulatory compliance for medical devices, be sure to highlight that in your answer. Talk about the specific regulations and guidelines you’ve worked with, and how you’ve implemented them into the design process. If you don’t have any direct experience, explain your understanding of the regulatory requirements that apply to medical device development, and discuss how you would go about ensuring compliance when creating a new device.
Example: “I have experience with regulatory compliance for medical devices, specifically FDA regulations. I’ve worked with the FDA to ensure that the devices I’ve designed meet the appropriate standards and requirements. I’m also familiar with ISO 13485, the international quality management standard for medical device manufacturers. I understand the importance of designing devices that are safe and effective for their intended uses, and I take the necessary steps to ensure that all of my designs meet the applicable regulatory requirements.”
