- Fujifilm (Trenton, NJ)
- …of the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Taiho Oncology (Princeton, NJ)
- …concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance. + Responsible for ... safety reports. + Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc. + Chairs the GSMT for responsible… more
- Atlantic Health System (Morristown, NJ)
- …projects are completed on time, within budget, and meet all clinical, regulatory , and technical requirements. The position works closely with Clinical Engineering, ... + Ensure all work complies with The Joint Commission (TJC), NFPA, AAMI, FDA , and applicable hospital standards. + Track project milestones and deliverables using… more
- Sanofi Group (Bridgewater, NJ)
- …the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions ... development strategies for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …components of the Clinical Study Reports and may support the development of regulatory documents; may perform quality review + Maintains compliance in accordance ... methodology & medical writing skills. Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial… more
- Sanofi Group (Morristown, NJ)
- …to technical outsourced staff. Responsible to ensure 100% accuracy , perform quality checks following SSDM established processes on all configuration requests + ... + Ensure desired configuration, compliance, business process, data integrity, quality , validation, security and system governance objectives under the responsibility… 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 or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a… more
- Bristol Myers Squibb (Warren, NJ)
- …projects to completion, and owns project summary reports. **Technical and Quality Responsibilities** + Understand new technologies, introduced to the Manufacturing ... and Quality Control areas, and serves as the first line...discipline. + Minimum of 5 years of experience in FDA -regulated industry (validation preferred), or 3 years and an… more
- Fujifilm (Wayne, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Overview** This entry-level position is responsible for technical repair and final quality inspection on assigned Endoscopic units. This position is responsible for… more
- Bristol Myers Squibb (Summit, NJ)
- …supervision of Warehousing Operations Management. The position must adhere to regulatory requirements while performing job functions. Job duties are performed within ... Communication and initiation of production deviations and assistance with quality investigations are required, as applicable. **Shifts Available:** Wednesday to… more