- Sanofi Group (Morristown, NJ)
- … regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, ... relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing… more
- Terumo Medical Corporation (Somerset, NJ)
- …with US Food and Drug Administration ( FDA ) regulations, international regulatory requirements, company policies, operating procedures, and quality system ... labeling requirements across US and international markets and ensures compliance with FDA , Terumo, and global regulatory standards. The Senior Labeling… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …assessments, method development, and validation activities, supporting compliance with global regulatory requirements and internal quality standards. The role ... processes. + Support packaging integrity and EO residual testing strategies. + ** Regulatory & Quality Compliance:** + Author and review microbiology-related… more
- Reckitt (Montvale, NJ)
- …with common software, including MSOffice. * Understanding of regulated products under regulatory bodies (EPA, FDA , BPR). * Proactive mindset fitting with ... Thinking, Problem-Solving, Formulation Expertise, Science, Chemistry, Intellectual Property Awareness, Regulatory Knowledge (EPA, FDA , BPR), Competitive Intelligence,… more
- Stryker (Mahwah, NJ)
- …You will work across multiple Stryker sites and collaborate with R&D, Quality , Regulatory , and Operations to ensure manufacturability, scalability, compliance, ... Implement and promote lean manufacturing and Six Sigma methodologies. + Collaborate with Quality , Regulatory , and Advanced Technology to ensure compliance with … more
- Sanofi Group (Morristown, NJ)
- …part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- Cytel (Trenton, NJ)
- …and associates across Cytel. + Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and ... junior colleagues, and driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape… more
- Integra LifeSciences (Princeton, NJ)
- …projects, and work cross-functionally. + Detail-oriented with a commitment to maintaining high- quality standards and regulatory compliance. + Experience with ... learn about bacterial endotoxin testing programs, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The… more
- Sanofi Group (Morristown, NJ)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Atlantic Health System (Newton, NJ)
- …disruption. * Perform electrical safety testing and documentation per organizational and regulatory standards (eg, Joint Commission, NFPA 99, FDA , ACR). * ... and advanced fluoroscopy equipment. This role requires expert-level troubleshooting, regulatory compliance oversight, and leadership in supporting the imaging… more