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.