Associate Regulatory Specialist

Associate Regulatory Specialist will 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. We are seeking  two(2)  Associate Regulatory Specialist for a 6 months contract position in Roswell, GA

SKILLS:

- Must be able to work on-site in Roswell, GA. No remote flexibility.
- RA Experience US (510Ks) RA Experience Latin America/International (Generating Dossiers and Obtaining Legalizations) Proficient at using computers that run Microsoft Windows.
- Proficient with Microsoft Office, especially MS Word and MS Excel.
- Experience with Internet Explorer.
- Ability to learn new systems.
- Ability to work independently.
- Good customer service experience using various forms of communication, including telephone, instant message, email, and direct face-to-face.
- Good organization and interpersonal skills.

RESPONSIBILITIES:

1. Maintain regulatory affairs files (eg scan, print, file) 
2. 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. 
4. Support the implementation of regulatory activities throughout the I-Flow facility. 
5. Assist in preparation and execution of Field Action activities. 
6. Provide regulatory support for International Registrations, DMRs, Technical files, Design Dossiers, etc. 
7. Support MDR Analyst with Medical Device Reporting (MDR's) and Medical Vigilance Reporting (MDV's).