- Biomat USA, Inc. (Research Triangle Park, NC)
- …plans related to corporate citations. + Coordinates and organizes final responses to regulatory inspections / audits ( FDA , EMA, CLIA/COLA, PPTA, State, Health ... Coordinates with donor centers and shared services with external inspections (eg regulatory , customer, etc.). Aids with audit planning, audit responses, and Plasma… more
- Fujifilm (Durham, NC)
- …on preventive and corrective actions. + Proficiency in validation documentation and regulatory standards (eg, FDA , EMA). + Familiarity with continuous ... new and existing facilities, ensuring compliance with industry standards and regulatory requirements. + **Align CQ/Ops Readiness Practices:** Align CQ/Ops Readiness… more
- Dentsply Sirona (Charlotte, NC)
- …drive innovation. **Make a difference** -by helping improve oral health worldwide. Sr. Regulatory Affairs Specialist + Leads regulatory submissions to obtain and ... 510(k) submissions, and technical files for CE marking + Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle… more
- Teleflex (Morrisville, NC)
- Regulatory Affairs Specialist **Date:** Aug 11, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... solutions that make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and submissions for projects and… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Actalent (Wilson, NC)
- …in quality assurance, deviation management, or a related role. + Knowledge of regulatory requirements (eg, FDA , EMA) and industry standards. + Strong analytical ... investigating, and resolving deviations from standard procedures, protocols, or regulatory requirements. This role ensures that all deviations are managed… more
- Kelly Services (Greenville, NC)
- …a related role in [industry, eg, pharmaceuticals, manufacturing, etc.]. * Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. * ... investigating, and resolving deviations from standard procedures, protocols, or regulatory requirements. This role ensures that all deviations are managed… more
- ThermoFisher Scientific (Greenville, NC)
- …a related role in [industry, eg, pharmaceuticals, manufacturing, etc.]. + Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. + ... investigating, and resolving deviations from standard procedures, protocols, or regulatory requirements. This role ensures that all deviations are managed… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …all electronic and hard-copy controlled documents in accordance with company policies and regulatory agency (eg, FDA and ISO) requirements. + Provide assistance ... to work as part of a team with minimal supervision. + Knowledge of FDA and/or GMP regulations preferred. + Prior ERP experience preferred. + Prior Microsoft Office… more
- Mentor Technical Group (Monroe, NC)
- …activities. + Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA , DEA, OSHA). + Manage Work through the ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more