- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- Kelly Services (Winston Salem, NC)
- …a safe working environment for all personnel. + Ensure strict compliance with FDA , EMA, and internal regulatory standards. + Maintain audit readiness and ... AAS or BS degree preferred. + Strong knowledge of GMP and regulatory requirements ( FDA , EMA), including biologics and cell/gene therapy operations. + Skilled in… more
- Astellas Pharma (Sanford, NC)
- …metrics relevant to job responsibilities. + Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. + May perform ... oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations. + Author, execute, review, or approve Quality Management… 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. **Qualifications:** While this position is listed as a Clinical Specialist, PLEASE NOTE that candidates that do not meet the minimum qualifications for this job as listed in the job description are… 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** Essential + BS or BE in Computer Science or related field. + Excellent verbal and written communication skills. + Proven problem-solving skills. + Strong Database development… more
- Fujifilm (Durham, NC)
- …testing. + 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:** + Bachelor's degree in Computer Science, Information Technology, or related field + 5 years of experience with TFS/Azure DevOps Server with build and release management + Strong… 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. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill,… 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. **Qualifications:** + BA/BS or equivalent professional work experience + A minimum of (5+ years desired) full-time experience in PACS System Administration (FUJIFILM Synapse preferred) or equivalent… 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** Experience + 4+ years previous… 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** Experience: + 8+ years of… more