- BeOne Medicines (Pennington, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... working experience and 2 years managing laboratory analysts in an FDA -regulated biotechnology, pharmaceutical company with progressive levels of responsibility are… more
- Teleflex (Maple Grove, MN)
- …R&D cleanroom, ensuring effective engineering builds, compliance with ISO and FDA requirements and seamless coordination between R&D and manufacturing functions. The ... to ensure pilot line readiness and process optimization. * Ensure ISO 13485, FDA , and GMP compliance across all pilot line activities. * Maintain calibration,… more
- MPE Inc. (Sturtevant, WI)
- …variation. + Manages complaints, CAPA, non-conforming products per applicable ISO13485 and FDA requirements. + Manage inputs and KPI metrics for management review ... process per ISO13485 and FDA requirements. + Maintain Medical Device Files and records...a customer interface role + Experience with customer and FDA audits + Experience in problem identification, resolution and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …centers in the United States consistently operate in full compliance with FDA and PPTA regulations, corporate quality standards, and industry best practices. The ... + **Compliance & Quality Oversight** + Ensure donor centers comply with US FDA , EMA, PPTA IQPP standards, CLIA/COLA, and state regulations. + Maintain audit and… more
- Veterans Affairs, Veterans Health Administration (Houston, TX)
- …compliance with all QC and QA requirements as per VHA policy, FDA /MQSA regulations, and ACR standards in mammography, tomography, breast ultrasound, and image ... the breast imaging section and assisting the department at annual FDA /MQSA inspections. When needed, the incumbent works closely with technologists, radiologists,… more
- Guidehouse (Arlington, VA)
- …doing things? Do you want to lead teams that solve complex problems for the FDA and other global public health agencies? Are you a fantastic communicator who is ... role, you will: + Lead a portfolio of change management initiatives to help FDA clients and other public health agencies adopt new technologies and innovative ways… more
- Boehringer Ingelheim (Athens, GA)
- …for assuring compliance of validated systems, process, equipment to current cGMP, FDA , EU, USDA, BIAH and BI corporate requirements. This includes, but is ... + Develops and Maintains local standard operating procedures to follow all FDA /EU/USDA regulations, as well as Corporate procedures. + Serves on assigned internal… more
- Medtronic (Minneapolis, MN)
- …resolve potential regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and Canadian submissions for product changes to ensure timely ... teams for regulatory issues and questions. + Interact directly with FDA and international regulatory agencies on most projects/products at reviewer level,… more
- University of Utah (Salt Lake City, UT)
- …, AND ABILITY** * Possess knowledge of all University of Utah Health/ ULEB / FDA / EBAA Policies and Procedures. * Know and follow current hospital and Office of ... Examiner procedures regarding organ/tissue donation in accordance with current FDA / KNOWLEDGE , SKILLS , AND ABILITY *...knowledge of all University of Utah Health/ ULEB / FDA / EBAA Policies and Procedures. * Know and… more
- State of Massachusetts (Canton, MA)
- …compliance surveys of mammography facilities in accordance with the FDA 's Mammography Quality Standards Act (MQSA). Additional responsibilities include performing ... of radiation accidents or incidents, in accordance with the State and FDA Mammography Quality Standards Act (MQSA). * Performs compliance inspections and… more