- 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
- Sumitomo Pharma (Austin, TX)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. ... Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion… more
- Parexel (Austin, TX)
- …development. * Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. * Collaborate with global teams to ... ensure consistency across markets while meeting US-specific requirements. * Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. * Support… more
- MD Anderson Cancer Center (Houston, TX)
- …*SECTION MISSION: *The Transfusion Medicine Section provides all CLIA and FDA -compliant services related to blood and blood product donation, testing, and ... very busy transfusion medicine service. Specific activities include compliance with CMS/CLIA, FDA , OSHA, AABB, CAP, JC and relevant state statutes and regulations.… 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
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical,...be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other… more
- Unilever (Austin, TX)
- …will also serve as the primary liaison with regulatory agencies such as the FDA and FTC. In addition to managing day-to-day quality and regulatory functions, this ... recurring issues as necessary. + Conduct internal audits and support third-party, FDA , and regulatory inspections. + Generate and analyze quality KPIs and trends… more
- Zimmer Biomet (Austin, TX)
- …validation, verification, regression testing, and cybersecurity to ensure compliance with FDA , ISO 13485, IEC 62304, and ISO 14971 standards. Monogram's ... for robotic medical device systems, ensuring compliance with applicable FDA and ISO regulations + You will develop and...and serve as the software quality SME during internal, FDA , and Notified Body audits + You will ensure… 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
- 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