If the sound of 510(k) doesn’t scare you…
If “ISO 13485” feels like a second language…
If you love the thrill of helping innovative medical devices cross the regulatory finish line…
Then you might be exactly who our client is looking for.
The Mission?
Join a team on the cutting edge of orthopaedic innovation! - You’ll be the bridge between big ideas and real-world, regulatory-approved solutions.
What you’ll actually do:
* Craft global regulatory strategies
* Own FDA, ISO, and CE compliance
* Build 510(k)s, PMAs, and other submission beasts
* Be the go-to with agencies and auditors
* Keep tabs on all post-market surveillance and quality systems
* Use your clinical + technical brain to shape future product designs
Join a fast-moving, forward-thinking team that is passionate about what they do!
You’ll need:
✅ Three + years of solid regulatory experience (ideally med device)
✅ Deep understanding of FDA + ISO frameworks
✅ Confidence with submissions and global reg strategy
Location: Flexible hybrid setup – (Would consider fully remote for the right candidate)