Job Summary
A staffing company has an open position for a Remote Regulatory Affairs Consultant.
Core Responsibilities Include:
- Providing insight on types of testing and endpoints that should be included
- Reviewing the work of an internal employee putting together a 510K
Must meet the following requirements for consideration:
- Recent experience interacting with the FDA
- Experience with submissions specific to renal products
- Have obtained a 510k without performing a clinical trial
- RA
- 510k submission of Renal products