- ARTIDIS (Houston, TX)
- …efficiency, and ensuring that our transformative technology consistently meets FDA requirements and internal quality benchmarks, ultimately supporting superior ... Execute all local Quality Management activities in compliance with FDA Requirements + Ensure compliance assurance and monitoring related...Sound knowledge of ISO 13485:2016 and an understanding of FDA Quality System Regulation (21 CFR Part 820) +… more
- Fujifilm (College Station, TX)
- …Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Bachelor's Degree and 7+ years of direct ... experience in pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments. + Degree in Engineering or Science discipline is… more
- Veterans Affairs, Veterans Health Administration (Temple, TX)
- …compliance with all QC and QA requirements as per VHA policy, FDA /MQSA regulations, and ACR standards in mammography, digital breast tomosynthesis, breast ... the breast imaging section and representing the department at annual FDA /MQSA inspections. Working closely with the technologists, radiologists, clinicians, and… 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
- Merck (Austin, TX)
- …across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written ... leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated expertise in leading regulatory filings across global… more
- Kedplasma (El Paso, TX)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and care of the donor… more
- United Therapeutics (Austin, TX)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient preference… more
- Biomat USA, Inc. (San Antonio, TX)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. * Attend… more
- Abbott (Plano, TX)
- …Review system. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... blueprint reading and experience with inspection sampling techniques. + Knowledge of FDA , GMP, ISO 13485. + Good communication and computer skills, including… more
- CBRE (Wilmer, TX)
- …CBRE self inspection, client self inspections, or any external agency inspections like the FDA . Has the responsibility to lead audits as well as serve as the primary ... preferred. Previous supervisory experience a plus. **CERTIFICATES and/or LICENSES** FDA , ISO, or similar quality assurance audit related certification preferred.… more