Job Summary
A medical contract research organization is searching for a person to fill their position for a Telecommute Medical Device Regulatory Affairs Manager.
Candidates will be responsible for the following:
- Submit and manage domestic product listings
- Prepare, submit, and manage regulatory clearance applications
- Participate as subject matter expert in internal and external quality system
Must meet the following requirements for consideration:
- Specific experience with US submissions
- BA/BS degree is required
- 7-10 years of experience in regulatory and/or quality assurance
- Skilled at interfacing with the FDA/CDER/OIR