- Chemours (Austin, TX)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Bio-Techne (Austin, TX)
- …global regulatory strategies, ensuring compliance with FDA and international medical device regulations. Monitor industry trends, analyze regulatory ... ability to manage workload independently. + Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and submission… more
- Astrix Technology (Fort Worth, TX)
- …EC Certificates (MDD /MDR) and associated documentation. **Key Requirements:** + 4+ years in medical device regulatory affairs + Experience with European MDR ... + Supporting EU MDR compliance and lifecycle change management for medical devices . + Works closely with site regulatory teams to manage and submit… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides … more
- Houston Methodist (Houston, TX)
- …within an academic research environment or FDA regulated industry + Experience in medical devices , diagnostics, or pharmaceuticals and/or within an academic ... and/or important safety related issues. + Perform high quality clinical review of regulatory forms and...of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and… more
- Trane Technologies (Tyler, TX)
- …or a related field within a regulated industry (eg, HVAC, automotive, aerospace, medical devices ). + Strong knowledge of global chemical regulations and ... for a sustainable world. We are seeking a talented Regulatory & Standards Materials Engineer to join our Materials...the employer uses to measure earnings by quantity or quality of production (so, for example, positions that may… more
- FREEMAN (Dallas, TX)
- …7-10 years of experience with product development in a regulated industry (eg, medical devices , aerospace). + Knowledge of lean product development principles. + ... Development Engineer to lead the development of innovative products that meet regulatory requirements and ensure customer safety. The ideal candidate will have a… more
- Edwards Lifesciences (Dallas, TX)
- …pathology and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device ... in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory...of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology… more
- Houston Methodist (The Woodlands, TX)
- …of the Medical Staff to educate and coordinate the activities of the quality and safety program. Participates in orienting Medical Staff and other hospital ... and clinical enhancements necessary to maintain or achieve a safe, high quality patient care environment. Provides appropriate medical direction in accordance… more
- Abbott (Irving, TX)
- …business competencies that drive results and continuous improvement. + Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
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