- Fujifilm (Trenton, NJ)
- …+ 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 (Trenton, NJ)
- …+ 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 (Trenton, NJ)
- …+ 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 (Wayne, NJ)
- …required + 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 (Wayne, NJ)
- …+ 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. + Must follow instructions and apply to real situations in a very quick manner. + Reach monthly targets on a consistent basis. **Qualifications:** + HS Diploma or equivalency is required. + Electronic… more
- Fujifilm (Trenton, NJ)
- …+ 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
- Sanofi Group (Morristown, NJ)
- …and Regulatory teams to interact and respond to request from the global regulatory agencies ( FDA , EMA and other agencies) + Co-lead with the scientific ... Our Medical Affairs function serves as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first… more
- J&J Family of Companies (Raritan, NJ)
- …validation and maintenance is preferred. + Demonstrated experience of cGxP regulations, FDA , EMA and other regulatory agencies. + Proven track record ... teams, foster a culture of compliance, and clearly communicate complex regulatory requirements. This role involves overseeing SOP revisions, CAPAs, Change Controls,… more
- Kelly Services (Burlington, NJ)
- …year in a supervisory role (3+ years preferred). + Strong understanding of cGMP, FDA , ICH, and other regulatory guidelines. + Experience with electronic batch ... a diverse team, maintaining the highest quality standards, ensuring regulatory compliance, and adapting to workplace challenges. **Schedule:** Monday-Thursday, 7:00… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …GLP-compliant bioanalytical workflows and method development. * In-depth knowledge of global regulatory expectations ( FDA , ICH, EMA) for PK and immunogenicity ... antibodies (NAb) in biological samples to support drug development and regulatory filing. **Essential Functions:** * Develops, validates, and implements immunoassays… more