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Regulatory Affairs Specialist III

Company: Careerbuilder US
Location: Alpharetta
Posted on: January 17, 2020

Job Description:

Role: Associate Regulatory Affairs Specialist III Duration: 6 months contract Location: Alpharetta GA Required Skills : Regulatory, Technical Files, 510K, STED Our Fortune 500 client is looking for Associate Regulatory Affairs Specialist III based out of Alpharetta GA Notes: Seeking a candidate who has regulatory experience with 510K, Technical Files and STED. Responsibilities (fundamental job duties): -- 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. 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 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 minimum requirements are: -- At least 1 yr. regulatory affairs experience. -- Experience writing STED or technical files preferred. -- Knowledge of EU MDR preferred. Please send your updated word format resume along with your best contact details to [Click Here to Email Your Resum--] or call me at 201-244-4303 BSC Solutions Inc., is a Global IT Solution provider headquartered in Troy, Michigan with operations in the US, India and the Middle East. BSC Solutions has over 15 years of IT and consulting experience to give cost effective solutions to many Fortune 1000 companies. Thanks & Regards, Sandra Williams Sr. IT Recruiter W:1 201-244-4303 [Click Here to Email Your Resum--] BSC Solutions, Inc. USA - DUBAI - INDIA 1000 John R. Rd, Suite 203, Troy, MI 48083 www.bscsolutionsinc.com

Keywords: Careerbuilder US, Alpharetta , Regulatory Affairs Specialist III, Other , Alpharetta, Georgia

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