Director of Regulatory Affairs Device

We are working with a small device company that is looking for a hands on Director of Regulatory Affairs with experience as follows:
510K submissions
Proactive communicator
Ability to multitask and manage multiple deadlines competently
Ability to raise risks and propose mitigations
Ability to work independently with minimal management
Bachelor's degree
Experience: Has dealt direct with the FDA on submissions and is able to work with R&D teams both domestic and EU to strategize on pathways for design compliance and approval.
This is a great opportunity to join a small-sized company and run a Regulatory program.
Chicago area.