Regulatory Affairs in a start-up medical device company

[CreatureofCompliance]

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.

 

[ChrisM]

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......

 

[d_addams]

The following advice applies to both Reg Affairs and Quality: Yes do this but only if there is a very experienced mentor at the organization to support you. Working at a startup you will learn a lot of things in a very short period of time. But you need a guide. Regulations and QMS design are very hard to navigate with no experience. The regulations are written vaguely with non-specific terms 'if it is likely', 'production equivalent', etc. which make it very challenging for inexperienced people to navigate with confidence. But with an experienced mentor at the organization who can offer advice and guidance to help navigate the grey you'll have much more experience than someone with the same time in job as someone from a large corporation in the same role.