- 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. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of… more
- Fujifilm (Durham, 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:** + BS or BE in Computer Science or a related field and/or equivalent work experience. + Thorough understanding of: + Microsoft Windows Server environments (Server 2012, Server 2016)… more
- Kelly Services (Winston Salem, NC)
- …qualification processes. + Strong understanding of GMP manufacturing unit operations and regulatory requirements ( FDA , EMA, ICH). + Excellent technical writing, ... **Job Title:** MSAT Engineer **Department:** Regulatory / Manufacturing Science and Technology (MSAT) **Location:** Winston-Salem, NC **Job Type:** Full-time, Exempt… more
- ThermoFisher Scientific (Greenville, NC)
- …logistics, supply chain management, or Customs Broker license. + Knowledge of pharmaceutical regulatory standards ( FDA , DEA) is a plus. + Strong analytical, ... teams to handle FTZ shipments in compliance with regulations. + ** Regulatory Compliance & Audit:** Conduct periodic self-audits, resolve discrepancies, file timely… more
- Kelly Services (Winston Salem, NC)
- …+ Working knowledge of deviation management and CAPA processes + Familiarity with FDA , EU, and ISO regulatory frameworks is preferred **Skills:** + Strong ... Specialist II helps ensure that products, materials, and processes meet regulatory requirements and internal standards. **Key Responsibilities:** + Maintain GMP… more
- Pfizer (Raleigh, NC)
- …Injectables experience, including buy-and-bill strategies and demonstrated knowledge of: Regulatory pathways ( FDA , EMA, Health Canada) and interchangeability ... public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses… more
- Cytel (Raleigh, NC)
- …comfortable interfacing with **senior executives** . + Experience interacting with ** regulatory agencies ( FDA /EMA)** and **key opinion leaders (KOLs)** . ... collaborating with a team of consultants and analysts to define optimal ** regulatory , clinical, and/or market access pathways** . + Develop **innovative solutions**… more
- Reckitt (Wilson, NC)
- …maintenance, and QMS frameworks. + Ensure documentation adheres to GDP standards and regulatory compliance ( FDA , ICH, ISO); support validation and hygiene design ... requirements. + Develop and manage project budgets, cash flow forecasts, and detailed implementation schedules for tableting and coating scope. + Mentor junior engineers and technicians in tablet manufacturing and coating operations. + Generate and manage… more
- Perdue Farms, Inc. (Lewiston Woodville, NC)
- …will act as the primary interface with internal, external, customer and regulatory (USDA and/or FDA where applicable) inspectors regarding sanitation related ... the implementation of Perdue Farms Sanitation Standards, while meeting or exceeding Regulatory / GFSI requirements, and Sanitation Key Performance Indicators at the… more
- Deloitte (Raleigh, NC)
- …support. + Regulatory Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + ... You will lead and deliver complex projects that drive innovation, regulatory compliance, and operational excellence for pharmaceutical, biotech, and medical device… more