- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... go-live.. Lead PE's must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Knowledge Base articles. + Maintains an expert working knowledge of current medical imaging products and related technologies. + Engineers must have the ability… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Strong command of Quality Management Systems (QMS), ISO standards, GMP, USP-EP, and regulatory requirements applicable to medical devices + At least 5 ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...Change Requests (BD- or Customer-Initiated)** + Stays informed of regulatory developments and advises BD and customers on their… more
- Bausch + Lomb (Trenton, NJ)
- …departments (eg, R&D/Project Management, Clinical/ Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device ... areas to provide input on study-related documents and issues (DMP, SAP, drug/ device supplies, CSR, etc.). + Provides clinical operations input in the identification,… more
- Sanofi Group (Morristown, NJ)
- …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... launch and maintain best-in-class drug delivery systems and connected medical devices that address patient unmet needs...market auto-injectors, pens, safety syringes, as well as connected medical device technologies, and we are gearing… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of up to 3 Tesla, which could dangerously affect any implanted medical devices made of ferrous material, potentially causing serious injury and/or death.… more
- Merck (Rahway, NJ)
- …and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, ... the development, commercialization, and transfer and sustained launch of medical devices and combination products globally. +...preferred. + Minimum of 10 years of experience in medical device or combination product engineering, with… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of up to 3 Tesla, which could dangerously affect any implanted medical devices made of ferrous material, potentially causing serious injury and/or death.** +… more
- Fujifilm (Wayne, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... or minimum 2 years repair experience working on related medical equipment. + Electronic and mechanical skills required. +...handle or feel objects, use electronic or mechanical repair devices , fine motor skill dexterity, reach with hands and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …(eg, presentations/publications focused on surgical device modeling, ISPOR Surgery or Medical Device SIG). + Has substantial hands-on experience planning and ... and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs, Market Access, Regulatory Affairs and Marketing + Interact… more