- Herbalife (Winston Salem, NC)
- …diploma or GED equivalent. **PREFERRED QUALIFICATIONS:** + Food and Drug Administration ( FDA ) other regulatory . + Experience using high Speed Mixer, Dryers, ... Fitz mill, Sweco, scales and tablet presses. + Current Good Manufacturing Practices (CGMPS). At Herbalife, we value doing what's right. We are proud to be an equal opportunity employer, making decisions without regard to race, color, religion, sex, sexual… more
- ThermoFisher Scientific (Greenville, NC)
- …worldwide medical device and combination product portfolio. This role ensures adherence to global regulatory requirements ( FDA 21 CFR Parts 4, 210, 211, and 820; ... preferred. **Knowledge, Skills, Abilities** + Deep knowledge of global regulatory frameworks ( FDA , ISO, EU MDR, ICH). + Proven experience leading global… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver… more
- Lilly (Durham, NC)
- …awareness within the organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping ... and equipment specific to parenteral products. + Familiarity with regulatory guidelines ( FDA , EMA, ICH) and experience with regulatory inspections.… more
- Lilly (Durham, NC)
- …and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and ... This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (… more
- Fujifilm (Holly Springs, NC)
- …requirements * Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports ... Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Integration, Customer Service, etc.). + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Fujifilm (Raleigh, NC)
- …systems. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally receives little instruction on day-to-day work and… more
- Fujifilm (Raleigh, NC)
- …others. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... into actionable user stories and system requirements. + Integrate input from regulatory , marketing, and implementation teams to maintain compliance and accuracy in… more