Job Summary
A contract research organization has a current position open for a Telecommute Regulatory Affairs Manager.
Core Responsibilities Include:
- Preparing, submitting, and managing regulatory clearance applications required for product market approvals
- Preparing and submitting USFDA Regulatory submissions
- Submitting and managing domestic product listings
Must meet the following requirements for consideration:
- Travel nationwide
- 7-10 years of experience in regulatory and/or quality assurance in a IVD medical device development and manufacturing environment
- Expertise and understanding of Class III IVD product entry into the US market
- Specific experience with US submissions for Medical Device and IVD products.
- Skilled at interfacing with the FDA/CDER/OIR
- Prior project management experience
