Associate Regulatory Affairs Specialist

We are looking for an Associate Regulatory Affairs Specialist I for a 8 months contract in Alpharetta, GA.

Responsibilities for Associate Regulatory Affairs Specialist: 

- Support regulatory compliance throughout the organization by performing the required activities that assure compliance with domestic and international regulations 
- Help refine and maintain systems for organizing and retrieving regulatory related information. 
- Maintain regulatory affairs files (eg scan, print, file) 
- Research, renew and obtain State Licensing where needed for the I-Flow facility. 3. Support and participate in audits performed by internal and external (eg, FDA, Notified Body, etc) representatives. 
- Support the implementation of regulatory activities throughout the I-Flow facility. 
- Assist in preparation and execution of Field Action activities. 
- Provide regulatory support for International Registrations, DMRs, Technical files, Design Dossiers, etc. 
- Support MDR Analyst with Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs).