• 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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  • 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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  • Ventricular Assist Device (VAD) Specialist

    Tufts Medicine (Boston, MA)
    …to clinical investigations and trials. 3. Ensure preventive maintenance is performed by Medical Engineering in compliance with regulatory requirements. 4. ... Ventricular Assist Devices (VADs) and VAD-related equipment. Responsible for device tracking, supply utilization and ordering, preventative maintenance, coordinating… more
    Tufts Medicine (08/23/25)
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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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  • Principal Regulatory Affairs Specialist

    Medtronic (Boston, MA)
    …of relevant experience **Nice to Have: Preferred Qualifications** + 7+ years of medical device regulatory affairs with roles showing increasing ... to labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance . + Monitor, evaluate, and enhance regulatory more
    Medtronic (08/23/25)
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  • Manager, Global Regulatory Affairs

    Hologic (Marlborough, MA)
    …science related field preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience ... streamline and enhance efficiency. + Promote a culture of compliance , collaboration and continuous improvement within the regulatory...proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device more
    Hologic (07/30/25)
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