- HCA Healthcare (Asheville, NC)
- …technical and non-technical resources and operations to meet organizational and regulatory requirements. + Execute programs for staff hiring, orientation, training, ... conduct. Contribute to achievement of department goals for service, quality, regulatory compliance, financial performance, and patient and employee satisfaction. +… more
- Novant Health (Charlotte, NC)
- … regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA . Responsible for qualification, validation, auditing of all critical processes,equipment, ... Novant Health. + Is a key member who ensures compliance with regulatory agencies, recommends an appropriate organizational structure and personnel plan for the… more
- Sumitomo Pharma (Morrisville, NC)
- …and external partners. Critical responsibilities include ensuring compliance with regulatory requirements, company procedures, and supporting the build-out and ... Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents. + Experience in tissue and cell-based… more
- Cambrex High Point (High Point, NC)
- …and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness and accuracy + ... TGA/DSC) + Able to comply to SOPs and have understanding of regulatory compliance + Working knowledge of scientific concepts, principles and procedures +… more
- GRAIL (Durham, NC)
- …laboratory equipment along with documenting activities in accordance with regulatory compliance guidelines. Laboratory equipment supported will range widely, but ... for traceability purposes and to assure compliance with CLIA/CAP, FDA 21 CFR part 820, and + ISO 13485...and safety guidelines + Work closely with quality and regulatory to determine, include, implement and follow the required… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... + Familiarity with material and device biocompatibility evaluation and associated regulatory requirements Preferred Qualifications + Doctor of Philosophy (PhD) in… more
- IQVIA (Durham, NC)
- …+ Ensures study level ADaM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and ... consistency in metadata use and development. + Actively monitors for new regulatory requirements related to data standards and/or data submissions; Communicates and… more
- Astellas Pharma (Sanford, NC)
- …approve associated protocols, reports, and deviations to ensure compliance with regulatory and internal standards. **Technical Leadership and Support:** + Serve as ... + Review and approve Product Specification documents to ensure alignment with regulatory and internal requirements. **Quality Systems and Compliance:** + Lead or… more
- Cambrex High Point (Durham, NC)
- …site procedures. + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness and accuracy + ... /validation and troubleshooting. + Able to comply to SOPs and basic regulatory compliance + Working knowledge of scientific concepts, principles and procedures +… more
- CBRE (Durham, NC)
- …instrument-related activities, focusing on operational efficiency, technical proficiency, and regulatory compliance, where applicable. This roles is considered a ... and administration. + Verify compliance with performance, safety, statutory, and regulatory requirements, and company policies, standards, and procedures. + Process… more