• Combination Device

    Insight Global (Rahway, NJ)
    Job Description Insight Global is seeking a Combination Device Development Project Manager to join a pharmaceutical client's Device Product & Process ... DPPD Team manages the development of the device constituent of our company's pipeline of combination...reports/dashboards/risk register that summarize key progress and issues on development programs across different device project more
    Insight Global (05/20/25)
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  • Scientist, Drug/ Device Combination

    Merck (Rahway, NJ)
    …focuses on the design, development , and commercialization of novel biologic/drug/vaccine- device combination products for safe and effective delivery to their ... sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic… more
    Merck (05/10/25)
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  • GRA Device Lead

    Sanofi Group (Morristown, NJ)
    Development , manufacturing, quality, supply chain) and drug product development . Combination product and drug delivery device systems technology is often ... on assigned projects. The role will represent the GRA Device perspective as a member of project ...lifecycle management activities for device aspects of combination product submissions. + Contribute to product development more
    Sanofi Group (04/15/25)
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  • GRA Device Lead, Associate Director

    Sanofi Group (Morristown, NJ)
    …closely with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development , manufacturing, quality, supply chain) and drug product ... team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro...part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development .… more
    Sanofi Group (05/15/25)
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  • Sr. Principal Device Engineer

    Pfizer (Parsippany, NJ)
    …for device lifecycle management of on-market medical devices and combination products + Develop change management technical impact assessments, design and ... accelerated development timelines + Contribute expert level knowledge of device standards, regulations, processes and/or technology to ensure project success… more
    Pfizer (05/21/25)
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  • Associate Director, Quality Assurance…

    Merck (Rahway, NJ)
    …JANUS IT system. This position interacts closely with cross functional teams, including Device Development & Technology (DD&T), working in the system in support ... to act as Lead System Owner of the Medical Device and Combination Product (MDCP) Design Controls...guidance to our Manufacturing Division and our Research & Development Division device functions and other personnel… more
    Merck (05/09/25)
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  • Associate Principal Scientist, Combination

    Merck (Rahway, NJ)
    …focuses on the design, development , and commercialization of novel biologic/drug/vaccine- device combination products for safe and effective delivery to their ... of design verification testing strategies for innovative combination products? Join our company's Device Product & Process Development (DPPD) Team, which… more
    Merck (05/08/25)
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  • Director, Global Regulatory Strategist, CGT…

    Bayer (Whippany, NJ)
    …Understand and communicate scientific principles and regulatory requirements relevant to global drug- device combination product development ; + Provide global ... etc.); + Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project ...regulatory assessments for requirements of drug- device combination products according to existing global… more
    Bayer (03/26/25)
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  • Senior Project Implementation Manager…

    Grifols Shared Services North America, Inc (Freehold, NJ)
    …countries and regions. **Summary** Grifols Diagnostic Solutions is seeking a Senior Project Management Manager to help oversee our West Coast customers. This ... coordinate the available GDS and third-party staff necessary for each go live project . This position is also responsible for collaborating with resource managers of… more
    Grifols Shared Services North America, Inc (04/08/25)
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  • Associate Principal Scientist, Analytical External…

    Merck (Rahway, NJ)
    …of contact for externalized analytical deliverables supporting medical device and combination product programs at various stages of development . The scope of ... manage externalized projects. + Lead analytical development for all medical device and combination product deliverables sited at selected external partners… more
    Merck (05/01/25)
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