- Merck (Raleigh, NC)
- …(biologics and/or vaccines). + Deep expertise in GMP requirements across multiple regulatory agencies ( FDA , EU, ROW) + Strong understanding of different ... and vaccines. As a trusted GMP compliance expert, you will drive regulatory excellence, support health authority inspections, and ensure robust corrective and… more
- Fujifilm (Raleigh, NC)
- …- I. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- J&J Family of Companies (Wilson, NC)
- …ICH, and ISO standards. + Understanding and experience in application of global regulatory ( FDA , EMA, etc.) guidelines in a biological or pharmaceutical ... and commitment to operating ethically and within the boundaries of regulatory requirements. + Excellent communication and interpersonal skills, with the ability… 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 (Holly Springs, NC)
- …requirements * Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Performs ... Bioassay ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role periodically interfaces with customersand cross-functional… 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
- VTI Life Sciences (Raleigh, NC)
- …site regulatory inspections + SME for presentation of cleaning validation to Regulatory ( FDA ), internal and external auditors. + Identify all necessary SOPs ... and need by dates and work with owning functions to ensure delivery + Work in partnership with QC teams to determine the appropriate CV methods and sampling strategies + Work in partnership with the Supply Chain teams to develop a material resourcing and… more
- Astellas Pharma (Sanford, NC)
- …specifications, protocols, and reports. + Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. **Required ... suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance. + Provide QA review and approval… more
- 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:** While this position is listed… more
- 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** + Minimum Associates Degree in… more