- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Republic, Mexico, Germany, Canada, and South America. Responsibilities: + The Project Manager will have the responsibility to oversee all business project management… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …of technical guidelines to assure execution of regulatory strategies and requirements . This is a fully remote role. **Primary responsibilities:** + Develops ... for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory … more
- ITW (Washington, NC)
- …to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including ... direct supervision. Performs other duties as assigned. **Position Skills and Experience Requirements ** : To perform this job successfully, an individual must be able… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …within the guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements , including FDA , ISO, Legal, Ethical, and bioMerieux-specific procedures. ... ensure the relationship between both companies will meet bioMerieux's capacity requirements , cost expectations, and quality standards. Primary Duties + Perform all… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …data, answering EM related questions and providing written responses as necessary. ** Requirements :** - PHD in a Life Sciences or relevant degree with minimum ... of 10 years relevant experience - Experience in dealing with the FDA regarding license submissions, inspections and audit follow-up required - Aeseptic/sterile… more
- Sumitomo Pharma (Raleigh, NC)
- …+ Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills in signal detection, risk assessment, and safety data ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- ZOLL Medical Corporation (Asheville, NC)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... Skills and Abilities + Proven sales leadership. + A valid driver's license Travel Requirements + 60% This job is a field-based position and requires that you reside… more
- Arc3 Gases (Dunn, NC)
- …the activities of medical plant operators. + Maintain all medical paperwork as per FDA requirements . + Run daily branch automated orders as per our established ... operations in compliance with US Food and Drug Administration ( FDA ) regulations to provide quality medical gas products to...training for new and existing employees as required by FDA and Arc3 policies. + Maintain a clean and… more
- J&J Family of Companies (Wilson, NC)
- …to thrive in a multi-cultural and matrixed environment. + Knowledge of FDA /EMEA regulatory requirements related to biologics and/or pharmaceuticals, preferred. + ... projects as needed in the capacity of a project manager or a subject matter expert. Conducts technical and...Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of production and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …operation. + Demonstrates sound knowledge and understanding of GMP requirements . + Dispenses and prepares necessary cleaning/sanitization reagents. + Assembles, ... description is intended to present the general content and requirements for the performance of this job. The description...or production manufacturing experience in a regulated industry (ie FDA , USDA, NRC) or a 2 or 4 year… more