- Sodexo (Greensboro, NC)
- …+ Calibrate and validate sterilizers in compliance with manufacturer, AAMI, and FDA standards + Maintain detailed service documentation and logs for compliance and ... reporting + Respond to on-site service requests and minimize equipment downtime + Adhere to all hospital safety procedures, including infection control protocols **What We Offer** Compensation is fair and equitable, partially determined by a candidate's… more
- ICON Clinical Research (Salisbury, NC)
- …of pro-active behaviors. + Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. + Ordering ... clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. + Monitoring and maintaining… more
- Cardinal Health (Raleigh, NC)
- …+ Review marketing materials related to customer services and FDA approved pharmaceuticals. + Review Business Associate Agreements, Confidentiality Agreements ... and Information Security Agreements **_Qualifications_** + 10+ years of experience preferred + Law firm or in-house healthcare experience preferred, including commercial transactions and fraud and abuse compliance expertise + Experience working with Group… more
- Sumitomo Pharma (Raleigh, NC)
- …Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency ... in BASE SAS and R, or other statistical software is advantageous + Effective verbal and writing skills **Education and Experience** + PhD or MS in statistics or biostatistics related field required. + PhD with 0-3 years or MS with 3 years related experience or… more
- GRAIL (Durham, NC)
- …diagnostic activities, ensuring consistency and compliance with relevant GCP, CLIA, FDA /IVDR, and other global diagnostic regulatory requirements. + Serve as a ... resource and subject matter expert on clinical and companion diagnostic regulatory standards and best practices. + Provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders. + Promote a… more
- UNC Health Care (Raleigh, NC)
- …audits and/or regulatory inspections of records and documents (eg FDA , CLGB/NSABP) **Other Information** Other information: **Education Requirements:** * Bachelor's ... degree (BSN) from an accredited school of Nursing. Master's preferred. **Licensure/Certification Requirements:** * RN NC LIC;BCLS * Certification in Specialty and Clinical Research preferred. **Professional Experience Requirements:** * Two years of relevant… more
- Honeywell (Charlotte, NC)
- …recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital transformation initiatives, process ... optimization for MSAT teams, and supply chain integration. **What We Offer** Opportunity to shape the future of AI-enabled manufacturing in the life sciences industry Leadership role with significant impact on product strategy and team development… more
- ITG Brands (NC)
- …regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations & ... upgrades, in order to supply solutions in line with legal requirements + Awareness of supplier developments, engineering/business strategies to drive Global Engineering standards + Perform other job-related duties as assigned **Qualifications** - REQUIRED… more
- Boehringer Ingelheim (Asheville, NC)
- …+ Performs all Company business in accordance with all regulations (eg, EEO, FDA , etc.) and Company policy and procedures. When violations are noted/observed they ... are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. **Requirements** Sales… more
- Fujifilm (Raleigh, NC)
- …+ 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. **Qualifications:** Experience + 5+ years of progressive experience in the Medical Informatics Sales. + Broad functional expertise in sales and experience in the areas of sales and marketing, strategic selling… more