Description
The essential job responsibilities of the regulatory affairs director position:- Leverage relationships with the FDA to successfully gain 510(K) clearance for the company's first-of-its-kind device
- Work cross-departamentally with R&D and other executives to provide regulatory guidelines and help execute a successful design
- Creatively work with the FDA to become a "policy setter" for this challenging space
- Develop and grow out the regulatory team as needed down the road
Job Requirements:
- Bachelor's Degree
- Submissions experience (preferrably 510(K) but PMA acceptable as well)
- Sharp eye for detail
- A background of regulatory creativity
- High energy but also collected
- A passion for start-up culture
The regulatory affairs director will report directly to the CEO.
To find out more about Real please visit www.realstaffing.com