Regulatory Affairs in a start-up medical device company

#1
Greetings All,

I am looking to change positions in the next few months and I have seen quite a few roles in RA for start-up companies. Their devices have not yet been approved for the market. I am wondering does anyone have any insight in to working for a start-up as an RA professional. I am thinking it would be an amazing opportunity to be involved from the beginning of the process, and a way to get invaluable experience with submissions, audits and strategizing. It is likely very different to working for established multinationals with mature portfolios.

Any insight is appreciated.
 
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#2
Oh yes..... it can definitely be very interesting, and be prepared to have to brief staff at all levels on just how bureaucratic and onerous it can be to obtain approval to sell medical devices on some countries ! You may even end up writing the product Technical File(s) (with input from engineers) because nobody else knows what needs to be in them, and you may also end up doing some of the testing yourself......
 
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