- 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: + Minimum five (5) years previous service-related experience. + Demonstrated ability at operating installation tools and test equipment. + Extensive knowledge and… more
- Medtronic (Charlotte, NC)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics ... Ability to read and understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable skills in Microsoft Office… 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 ... of the Perdue Farms Sanitation Standards, while meeting or exceeding Regulatory / GFSI requirements, and Sanitation Key Performance Indicators. The Site… more
- Kelly Services (Greenville, NC)
- …quality systems in a pharmaceutical or GMP-regulated environment. + Solid understanding of FDA , EMA, and ISO regulatory frameworks. + Strong root cause analysis ... and resolution of deviations from standard operating procedures, protocols, or regulatory requirements within a GMP-regulated environment. This role plays a key… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Amgen (Holly Springs, NC)
- …in new facility start-up or tech transfer projects + Expertise in global regulatory requirements ( FDA , EMA, etc.) + Strong background in laboratory compliance, ... improvement initiatives. The role ensures alignment with cGMP standards, regulatory expectations, and Amgen's global quality systems. **Strategic Leadership** +… more
- Fujifilm (Holly Springs, NC)
- …* Ensures that the quality agreement is organized based on segments of work and regulatory requirements including FDA , EU, and other regulatory agencies * ... assurance in a GMP environment *Experience in developing and implementing regulatory strategies **Preferred Requirements** * Training and/or familiarity with Quality… more
- Reckitt (Wilson, NC)
- …to identify and integrate cutting-edge technologies for performance optimization. + Drive regulatory alignment (GMP, FDA , ISO, EHS) across automation activities ... design using AutoCAD Electrical or EPLAN. + Experienced in regulatory compliance: GMP, FDA , ISO 9001/13485, EHS, electrical codes, and safety standards. +… more
- Novant Health (Winston Salem, NC)
- …Complies with all regulatory requirements related to the conduct of research ( FDA , GCP, IRB, ICH). Assures regulatory submissions for all protocols, adverse ... Works with Sr. team members to prepare for and attend sponsor and/or FDA audits. Develop knowledge to understand protocol feasibility. With leader or senior team… more
- Sumitomo Pharma (Raleigh, NC)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more