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Associate Regulatory Affairs Specialist III

Company: Tech Providers Inc.
Location: Alpharetta
Posted on: May 16, 2020

Job Description:

Job Title: Associate Regulatory Affairs Specialist III Location: Alpharetta, GA - 30004 Duration of assignment: 06 months contract Job Description: 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): 1. Maintain regulatory affairs files (e.g. 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 (e.g., FDA, Notified Body, etc) representatives. 4. Support the implementation of regulatory activities throughout the I-Flow facility. 5. Assist in the 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 (MDRs) and Medical Vigilance Reporting (MDVs). The hiring manager is seeking a candidate who has regulatory experience with 510K, Technical Files and STED. The minimum requirements are At least 1 yr. regulatory affairs experience. Experience writing STED and technical files. Knowledge of EU MDR preferred

Keywords: Tech Providers Inc., Alpharetta , Associate Regulatory Affairs Specialist III, Other , Alpharetta, Georgia

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