Title: Regulatory Affairs
Location: Alpharetta, GA
Duration: 6+ months
Job Description:
- Seeking a candidate who has quality/regulatory experience with 510K, Technical Files and STED.
- At least 1 yr. regulatory affairs experience.
- Experience writing STED or technical files preferred; engineering background; tech writing exp.; revising docs; prepare submissions/dossiers.
- 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.
Responsibilities (fundamental job duties):
- Maintain regulatory affairs files (e.g. scan, print, file)
- Research, renew and obtain State Licensing where needed for the I-Flow facility.
- Support and participate in audits performed by internal and external (e.g., 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).