Supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's de ...gree. Typically reports to a supervisor or manager. Occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. Typically requires 2 -4 years of related experience.More Show Less
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About The Job. Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist II will be primarily responsible for supporting compliance with applicable FDA, DEA, State Board of Pharmacy and OSHA regulations as well as all applicable company policies. The Regulatory Affairs Specialist II will assist and serve as a back-up to the Regulatory Affairs Specialist I & III for certain compliance critical tasks as required. The Regulatory...
Title. Regulatory Affairs Specialist II – Hybrid. Location. 9400 Jeronimo Rd, Irvine, CA 92618. Duration. 12 months. MAX PAY RATE. $45.00/hr. $50.00/hr. Key Skills. Regulatory Affairs, Labeling, IVD, IVDR, CE Marking, In Vitro Diagnostics. Work Schedule. Hybrid (3 days a week. Core days: Tuesday/Thursday, with an optional third onsite day). Role Overview. Support the EU In Vitro Diagnostic Regulation (IVDR) transition activities, specifically for...
Overview. At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. . Why work at Spacelabs. Because lives depend on you. . The Regulatory Affairs Specialist II supports the ...
Regulatory Affairs Specialist II #24-07006. Location. Swiftwater, PA 18370. Pay. $56. . $60/hr. Benefits. Assignment. Contract W2. Length of Assignment. 6 months with possibility to extend. Reason for opening. Backfill. Onsite Flexibility. Hybrid 2-3 day in office. Work Schedule. M-F 8-hour day, 8am-4pm, some flex 1st shift. UCS or GC candidates only. Overview of the Position. The Regulatory CMC Specialist will work closely with the Regulatory Si...
Start Date: 10/28/2024 Duration: 0-12 month(s) End Date: 10/27/2025. Description/Comment:Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, p...
