Regulatory Affairs Specialist Interview Questions | Glassdoor

Regulatory Affairs Specialist Interview Questions

46

Regulatory affairs specialist interview questions shared by candidates

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What do you know about the company? Recent news?

1 Answer

Just read the recent news on their website and regurgitate as needed.

Does FDA approve safe devices? Have you supported audits? Have you worked on 510(k) submissions?

1 Answer

How many medical device and pharmaceutical manufacturers are there in the US?

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What regulation number applies to regulatory affairs?

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I was asked a highly technical question, which wasn’t necessarily related to the job. I simply said that I could not answer. I don’t believe I was expected to know the answer, but it perhaps was a way to observe my approach and how I would handle such situations. Otherwise, I think the interview was challenging yet to the point and fair for the right candidate.

The manager asked me if I'm familiar with certain procedures for QMS.

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What did you do in your 'x' position? What were/are your achievements (either in a position or in general)? In this job, you'll be working with ... duties. What experience do you have, working with it?

What did you like about your last job?

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