- Cytel (Austin, TX)
- …team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development plans. + Collaborative, ... entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. + Minimum of a Masters in Mathematics, Biostatistics, or a related… more
- Leprino Foods (Lubbock, TX)
- …production and to confirm compliance with governmental regulatory specifications (OSHA, FDA , building codes, etc.). + Prepares and implements Authorization for ... Expenditure (AFE) by coordinating with production management, as well as other outside sources to obtain input and review. + Prepares specifications, drawings, and layouts. You Have At Least (Required Qualifications): + Bachelors degree in mechanical… more
- Globus Medical, Inc. (San Antonio, TX)
- …responsible for performing human tissue processing activities in accordance with FDA regulations, AATB Standards and SOPs. **Essential Functions:** + Prepares ... sections of human tissue for surgical implantation + Utilizes special techniques, instrumentation, and equipment to evaluate, cut, shape, grind and package tissue to exacting specifications and protocols + Accurately completes paperwork and performs data entry… more
- ThermoFisher Scientific (Austin, TX)
- …all subjects' and screening failure paperwork is kept with the study to meet FDA requirements. + Ensures physician reviews all clinical labs, ECGs and other tests as ... required. + Develops screening tools and source documents to ensure adherence to all inclusion/exclusion criteria. These documents include Medical History, Physical Exams, Study Dates and Information, Study Demographics, Study Admission Records,… more
- TreeHouse Foods, Inc. (Carrollton, TX)
- …samples for shipment as needed. . Ensure compliance with industry regulations such as FDA , GMP, HACCP, and ISO standards. . Adhere to food safety and workplace ... safety protocols in alignment with company policies. **_Important Details:_** . This is a full-time, on-site role on third shift. Occasional flexibility may be required to support alternate shifts. **_You'll fit right in if you have:_** . High school diploma… more
- Houston Methodist (Houston, TX)
- …conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research ... protocols and $70.3 million in extramurally funded translational research programs. Houston Methodist is an Equal Opportunity Employer. more
- Fujifilm (Austin, TX)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** Professional Experience: + 5-10 years… more
- UTMB Health (Galveston, TX)
- …IQ/OQ/PQ testing of LGI-Flag outputs, supplying evidence for CLIA, CAP and FDA SaMD compliance audits. + Monitor daily algorithm runs, investigate interface ... exceptions, and fine-tune threshold parameters to balance sensitivity and specificity for disorder detection. + Develop user dashboards and training materials that explain LGI-Flag scoring tiers, clinical actionability, and workflow impact for laboratory and… more
- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. Key Performance Indicators: + Revenue and sales bookings… 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 ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more