- Kedplasma (Duncanville, TX)
- …with KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... 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… more
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... in Tokyo with over 70,000 employees across four key business segments of healthcare , electronics, business innovation, and imaging. We are guided and united by our… more
- Medtronic (Houston, TX)
- …operating room, so healthcare /surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable… more
- ZOLL Medical Corporation (Dallas, TX)
- …and internal training + Knowledge of industry specific cybersecurity frameworks and regulatory requirements such as FDA Pre and Post-market Guidance on ... the design of security-related features, and the delivery of cybersecurity regulatory requirements. + Assist with SBOM management utilizing enterprise-wide tooling.… more
- Abbott (Austin, TX)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...manufacturing processes and equipment, in accordance with applicable medical regulatory standards.25% + Performs process and equipment improvement and… more
- Kedplasma (Houston, TX)
- …with cGMP, KEDPLASMA DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...records and determines if records comply with SOP and regulatory requirements and ensures corrective action(s) as needed. .… more
- ARTIDIS (Houston, TX)
- …the current diagnostic process and benefit both the patient and the healthcare system. ARTIDIS enables professionals to design personalized cancer treatment plans ... efficiency, and ensuring that our transformative technology consistently meets FDA requirements and internal quality benchmarks, ultimately supporting superior… more
- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... customer sites as directed by service management. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
- Wolters Kluwer (Coppell, TX)
- …planning, and defining and tracking success metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data ... machine-readable formats and SaaS-based solutions that power decision-making across the healthcare ecosystem. The Lead Product Manager translates customer and market… more
- Abbott (Plano, TX)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Abbott is a global healthcare leader that helps people live more fully...and experience with inspection sampling techniques. + Knowledge of FDA , GMP, and ISO 13485. + Good communication and… more