Job Summary
A medical contract research organization is searching for a person to fill their position for a Remote Regulatory Affairs Manager.
Candidates will be responsible for the following:
- Submitting and managing domestic product listings
- Leading and completing labeling reviews
- Assisting research personnel
Qualifications for this position include:
- Travel nationwide
- Expertise and understanding of Class III IVD product entry into the US market
- BA/BS degree is required
- A minimum of 7-10 years of experience in regulatory and/or quality assurance
- Skilled at interfacing with the FDA/CDER/OIR