- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- Fotona (Irving, TX)
- …to lead regulatory and corporate compliance efforts, with a strong focus on FDA readiness and enterprise-wide policy governance as we expand our US presence. This ... resilience in a dynamic, fast-paced environment. Key Leadership Responsibilities: Regulatory & FDA Compliance Strategy + Serve as the organizational lead for all … more
- Kedplasma (San Antonio, TX)
- …developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory bodies, as required. + Maintains… more
- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- MD Anderson Cancer Center (Houston, TX)
- …* Ensure compliance with all applicable regulations, guidelines, and standards (eg, FDA , GLP). * Coordinate and manage the informed consent process for clinical ... * Participate in audits and reviews, including shadowing assignments. * Support FDA submissions and participate in assigned research audits. * Maintain schedules for… more
- Houston Methodist (Houston, TX)
- …inspections and audits to ensure compliance with Federal Drug Administration ( FDA ) regulations and cGMP Core policies and procedures. **FINANCE ESSENTIAL FUNCTIONS** ... positive language principles + Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and...(21 CFR Parts 210/211, Medical Device Regulations, ICH and FDA guidances, etc.) and the ability to apply them… 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
- 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. The incumbent works closely with technologists, radiologists, clinicians, and… more
- BioBridge Global (San Antonio, TX)
- _QualTex Laboratories is an FDA -registered and CLIA-certified organization that provides state-of-the-art, high volume capacity donor screening and biological ... international and local regulations, such as AABB, AATB, ISO, FDA , GHA, and EU, etc. Maintain a positive work...retention. Must maintain familiarity of regulatory/quality compliance, to include FDA , EU, ISO, GHM, cGMP, OSHA, etc. Must maintain… more
- Abbott (Austin, TX)
- …design controls and regulations for medical device development, (ISO134851, ISO13485, FDA ). + Strong technical experience in mechanical or chemical engineering with ... of low cost, high volume electronic products. development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device… more
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