Duration:0-3 month(s)
Description/Comment: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 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).
Additional Job Details:seeking a candidate who has regulatory experience with 510K, Technical Files and STED; The requirements are: • At least 1 yr. regulatory affairs experience. • Experience writing STED or technical files preferred. • Knowledge of EU MDR preferred. •
Last updated on Mar 19, 2019