You didn't get into Regulatory Affairs to tick one box forever.
And you certainly didn't sit through ISO 13485 training just to be the PMS person.
If that's what your role has become, one thing, over and over again, then you'll want to read on.
If you want the full RA experience ... technical files, submissions, post market, change control and conversations with Notified Bodies and competent authorities then I have the role for you.
The business are looking for a Regulatory Officer.
Not someone who has already done everything - they don't need a finished product.
Instead, they want someone with a solid RA foundation. Someone who understands medical device regulations and most importantly has the desire to learn and grow in their career. The right attitude is everything for this business as they take the culture seriously.
The company were acquired a couple of years ago and now there's a big focus on the European market. With plans of new products, there's a huge growth potential and they need someone to be part of that.
Throughout a typical week, you would:
* Assist with maintaining technical files.
* Support regulatory submissions and compliance changes.
* Communicate with EU reps and competent authorities.
* Get involved in change control and new product introduction.
If you're early to mid career in RA and thinking "I want more exposure" then this could be the move you need.
It's a small team, two others plus the QARA Manager.
Based in Derby (2/3 days onsite per week)
If you're open to a conversation, drop me a message and I'll share the full details.
And if it's not for you but you know someone who's hungry to grow in Regulatory, send them my way.