- VTI Life Sciences (San Diego, CA)
- …environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP ... and preliminary problem diagnosis. + Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: + Bachelor's degree or higher in… more
- Sysco (Ankeny, IA)
- …food safety regulatory requirements (Federal, State/Provincial and, Local) including US FDA Seafood HACCP, FSMA Preventive Controls for Human Foods, FSVP, 204 ... Sysco experience. + Knowledge of product traceability + HACCP, ServSafe, FDA Preventive Controls Qualified Individual certification preferred + Understanding of Food… more
- United Therapeutics (Houston, TX)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... in relation to regulatory findings for IACUC, USDA, and/or FDA regarding animal care. + Authorize changes to IACUC...Serve as subject matter expert for USDA, AAALAC, and FDA inspections regarding all animal care processes **Minimum Requirements**… more
- University of Utah (Salt Lake City, UT)
- …instruments, and non-surgical medical devices. Conduct activities in compliance with FDA QSR's and ISO 13485. Ideate and develop concepts, develop SolidWorks ... instruments, and non-surgical medical devices. Conduct activities in compliance with FDA QSR's and ISO 13485. Ideate and develop concepts, develop SolidWorks… more
- Takeda Pharmaceuticals (Boston, MA)
- …as global and/or regional regulatory lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for all US FDA submissions ... of contact with health authorities and lead and manage FDA meetings. + Define strategies, provide tactical guidance to...of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more
- Boehringer Ingelheim (St. Joseph, MO)
- …US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned projects. This role is responsible ... for linking regulatory affairs information to internal and external stakeholders ( FDA ) to ensure sufficient and efficient communication through activities such as… more
- Abbott (San Diego, CA)
- …risk assessments and contribute to risk mitigation strategies aligned with FDA and international cybersecurity guidance. + Implementation of security risk controls ... ComplieswithU.S. FoodandDrugAdministration ( FDA )regulations,otherregulatoryrequirements, Companypolicies,operatingprocedures,processes,andtaskassignments.… more
- UTMB Health (Galveston, TX)
- …Scientist II will be assigned as a Study Director, as defined by the US FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point ... and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize...regulations or under quality systems that utilize the US FDA GLP regulations as a reference standard. The Regulatory… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory ... agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and organizes Regulatory files for… more
- University of Utah (Salt Lake City, UT)
- …and international research consortia as needed. 7. Prepare, submit and maintain IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research ... involved. The incumbent functions independently under minimal supervision, following FDA , Good Clinical Practice, IRB , NIH ,...both English and Spanish** Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of… more