• Product Safety & Risk Engineering Expert

    Philips (Cambridge, MA)
    …Monitoring Systems/Products are safe, reliable, and compliant with all applicable regulatory/ quality standards. **Your role:** + Will guide and facilitate safety ... activities such as: creation/maintenance of risk management plans/matrices, ensuring completeness/ quality of risk controls and traceability between risk management… more
    Philips (04/23/25)
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  • Head of Site Regulatory -Regulatory Site Office

    Sanofi Group (Framingham, MA)
    …a pharmaceutical or biotech organization. + Significant knowledge and experience with FDA /EMA/TGA/HC regulations + Proficient in computer software programs and ... from infectious diseases and bring hope to patients and their families. The Quality Assurance Department is responsible for providing oversight on all GMP activities… more
    Sanofi Group (04/04/25)
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  • Senior Manager, CMC Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …through nextGen portals is a plus. + Interact with manufacturing and quality groups, partner organizations, regarding CMC issues. + Independently manage preparation ... local and/or global functional units [OPCJ CMC RA, Factory, Quality , MPDD, OPDC/OPEL Tech Ops] as well as affiliates,...investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda +… more
    Otsuka America Pharmaceutical Inc. (04/25/25)
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  • Clinical Veterinarian

    Charles River Laboratories (Boston, MA)
    At Charles River, we are passionate about improving the quality of people's lives. When you join our global family, you will help create healthier lives for millions ... animal's life as well as roles in compliance monitoring, quality management and safe work practices when working with...that relate to animal care and use (Eg, USDA, FDA , AAALAC). + Make recommendations and assist in establishing… more
    Charles River Laboratories (04/03/25)
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  • Engineer: Sr. Electrical Design Engineer

    Nanobiosym, Inc. (Cambridge, MA)
    …build test fixtures for hardware validation and functional testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance. ... designing advanced PCB systems, driving embedded hardware development, and delivering high- quality products to market. This is a hands-on, technical leadership role… more
    Nanobiosym, Inc. (02/24/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …and guidelines. - Confirms submission documents are accurate, compliant, and high- quality to allow for smooth and expeditious approvals from regulatory authorities. ... with GRA department to execute departmental initiatives to improve overall efficiency, quality , and/or output. - Assess and develop innovative ideas to move GRA… more
    Otsuka America Pharmaceutical Inc. (04/23/25)
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  • Associate Project Engineer, Systems

    Globus Medical, Inc. (Methuen, MA)
    …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... validation of medical robotic systems, ensuring that electrical, mechanical, and software components work seamlessly together. You will work alongside top surgeons,… more
    Globus Medical, Inc. (05/09/25)
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  • Hardware Test Engineer

    Globus Medical, Inc. (Methuen, MA)
    …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... requirements. You'll work closely with cross-functional teams including hardware design, software , and systems engineering to ensure our devices are robust, safe,… more
    Globus Medical, Inc. (05/07/25)
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  • Regulatory Affairs Program Manager Digital…

    Olympus Corporation of the Americas (Westborough, MA)
    …regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a medical device and Machine Learning. + Assess impact ... 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven medical devices ( Software as a Medical Device) ideally with… more
    Olympus Corporation of the Americas (04/23/25)
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  • Associate Director, Promotion Compliance Strategic…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …for consistent messaging. + Serves as the primary contact/liaison with the FDA Office of Prescription Drug Promotion (OPDP), responsible for establishing working ... procedures, as appropriate. + Recommends improvements to labeling policies, processes, quality , and system tools. Manages contracts for contractors and consultants.… more
    Otsuka America Pharmaceutical Inc. (04/17/25)
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