- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Pentax Medical (Montvale, NJ)
- …and compliance with customs documentation requirements. + Support International product registrations. Requirements of Senior Regulatory Affairs Specialist ... specialist will work under the guidance of a seasoned manager to ensure PENTAX Medical's products for Endoscopes and...related field (Masters preferred) + Three-five years' experience in Regulatory Affairs for a FDA regulated employer… more
- Bristol Myers Squibb (Princeton, NJ)
- …Read more: careers.bms.com/working-with-us . **Summary:** The Director, Commercial Data Product Owner will implement and operationalize the commercialization data ... product strategy defined by the Executive Director. This role...management procedures aligned with Bristol Myers Squibb policies and regulatory requirement **Adoption & Value Realization** + Develop and… more
- Integra LifeSciences (Princeton, NJ)
- …and development of new or improved products in close collaboration with Product Development, Project Management, Regulatory , Marketing, Corporate and Site QA ... outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Senior Manager of the Tissue Technology (TT) Design Assurance Engineering department is… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Summary:** The Executive Director, Commercialization Data Business Product Owner serves as the enterprise leader for commercialization ... key competitive advantage for the organization. **Responsibilities:** **Set Commercialization Data Product Vision & Strategy** + Define and communicate the long-term… more
- Bristol Myers Squibb (Summit, NJ)
- …Manager Sterility Assurance is responsible to act as the SME during regulatory inspections. **Duties/Responsibilities** + To support final product testing and ... years of leadership/managerial experience required. + Experience in participating and supporting regulatory audits preferred: FDA , MHRA, PMDA, etc. + Experience… more
- Wolters Kluwer (Princeton, NJ)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the...Principal SaMD TPM acts as a bridge between engineering, product , regulatory affairs, clinical, and quality assurance… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... team, Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality, Legal, Privacy and Finance. External… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and tools to optimize efficiency and quality. + Collaborate closely with product management, hardware engineering, quality assurance, and regulatory affairs ... are seeking a highly experienced and visionary Sr. Software Manager to lead and inspire a team of talented...the medical device industry, with a strong understanding of regulatory requirements (eg, FDA 21 CFR Part… more
- Stryker (Mahwah, NJ)
- As the Advanced Operations & Manufacturing Engineering Manager for New Technology & Product Introduction, you will lead a team responsible for transitioning new ... with Quality, Regulatory , and Advanced Technology to ensure compliance with FDA , ISO, and internal standards. + Identify and implement NPI best practices across… more
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