We've partnered with a surgical robotics company in San Francisco as they are looking to onboard a high-level regulatory affairs consultant to their team. They just had a successful meeting with the FDA after a pretty aggressive pre-submission and are likely to be sent to SteP for medical devices. They also just received their latest round of seed funding in September 2023; overall they are in a great place to grow!
The ideal candidate they are looking for should possess the following:
- 12 years of regulatory affairs experience with medical devices
- Strong knowledge of software as a medical device and the robotics landscape
- Ability to navigate FDA discussions and general regulatory strategy
- De novo submission experience a huge plus - A candidate that is looking to get their hands a little dirty (as it is a start-up)
