- Terumo Neuro (Aliso Viejo, CA)
- …+ Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room monitoring and validation activities, ... four (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring. 4. EN… more
- Nuvance Health (New Milford, CT)
- …of workflow. * Ensures section compliance with all regulatory requirements (ie FDA , TJC, CAP, State of CT, NYS) by actively reviewing publications/standards. Section ... promote continuous quality improvement. * Prepares and submits various reports (ie QA, FDA reportables etc.) defined at the section level. * Responsible for all… more
- PCI Pharma Services (Bedford, NH)
- …PLC & SCADA control system. + Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus. + Demonstrated proficiency ... Word, MS Excel, MS Project, MS Power Point, + Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices. + Effectively support internal and… more
- University of Miami (Miami, FL)
- …to assist in responding to queries from regulatory agencies including the FDA . + Tracks proposals and other study relevant documentation through signature/approval ... and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices. + Establishes and… more
- Endo International (Rochester, MI)
- …a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Proficiency with various ... periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals… more
- Abbott (Pleasanton, CA)
- …and issues. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and ... and issues. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …(NABP) regulations. + Strong knowledge of global regulatory requirements, particularly FDA , EU MDR/IVDR, and other major markets' regulations. + Knowledge of ... organizing and validating device data for submission and registration with the FDA GUDID database. + Demonstrated success in regulatory strategy development and… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + Monitor training compliance ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… more
- CHS Inc. (Hermiston, OR)
- …documenting of all feed manufactured during shift. + Maintain accurate production and FDA records, entering data into Excel spreadsheet. + Mix and prepare livestock ... and enforce all company policies & procedures, adhere to all safety & FDA requirements. + Effectively communicate with managers, co-workers, and customers. + Perform… more
- University of Miami (Miami, FL)
- …SOPs are in compliance with relevant rules and regulations such as the FDA , CLIA, state testing requirements, Joint Commission, etc., managing FDA reportable ... events, errors and deviations, performing self-inspection, and auditing, educating clinical team, reviewing and investigating safety events. + Meets with QA Medical Director and Laboratory Director for final assessment of quality data, outliers, and corrective… more