• Senior Counsel ( Medical Device )

    Fujifilm (Boston, MA)
    …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US government… more
    Fujifilm (08/08/25)
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  • GRA Device Lead (Director)

    Sanofi Group (Cambridge, MA)
    …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... mindset and drives a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards. This critical...regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory… more
    Sanofi Group (07/15/25)
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  • Associate Director, Device Clinical…

    Takeda Pharmaceuticals (Lexington, MA)
    …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** ** Device Clinical Strategy & Risk… more
    Takeda Pharmaceuticals (06/06/25)
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  • Senior Specialist, Drug/ Device Combination…

    Merck (Boston, MA)
    …medical devices and combination products globally. * Experience in design controls, device risk management, medical device , complex combination product ... divisional and local site procedures for safety, quality, and regulatory compliance * Understand the big picture,...of decisions and expectations * Lead technical investigations of medical device and combination product needs for… more
    Merck (08/29/25)
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  • Lead Microbiology Technician

    Integra LifeSciences (Braintree, MA)
    …preferred. + 5+ years GMP/GLP laboratory experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance , or other regulated industry + ... of new or improved quality control systems as needed. + Ensure compliance with industry regulations, company policies, and safety standards during the transition… more
    Integra LifeSciences (08/08/25)
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  • Microbiology Technician II

    Integra LifeSciences (Braintree, MA)
    …discipline. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance , or other cGMP regulated product ... US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **ESSENTIAL DUTIES AND… more
    Integra LifeSciences (08/08/25)
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  • Quality Control Technician II, Analytical

    Integra LifeSciences (Boston, MA)
    …required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance , or other cGMP regulated product ... US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. + Responsible for performing… more
    Integra LifeSciences (07/31/25)
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  • Medical Device Assembler…

    Medtronic (Billerica, MA)
    …and writing in English. **Preferred Qualifications (Must Have!):** + Prior experience in the medical device or electronics industry. + Knowledge of ISO and FDA ... up to 6% match + Comprehensive benefits plan, including medical , dental, vision, and more + Fully subsidized Bachelors...quality checks and inspections on soldered components to ensure compliance with regulatory and company guidelines. +… more
    Medtronic (08/28/25)
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  • Senior Medical Device Software…

    Medtronic (Newton, MA)
    …software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, ... that enhance the usability and functionality of our advanced medical devices. The Senior Software Engineer will be a...The Affera Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias.… more
    Medtronic (08/29/25)
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  • Senior Regulatory Affairs Specialist

    Fresenius Medical Center (Lexington, MA)
    …regulations. * Maintains corporate regulatory files including EU technical files/documentation ( Medical Device Directives & Medical Device ... Reviews and approves Engineering Change Orders in accordance with regulatory requirements. * Participates in compliance related...as a Regulatory Affairs Specialist in the medical device field or (ii) a Master's… more
    Fresenius Medical Center (08/20/25)
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