• Senior Scientist - Commercial Manufacturing / GMP

    ThermoFisher Scientific (Boston, MA)
    …Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + Collaborate cross-functionally with ... or impurity methods. + Familiarity with GMP, CLP, and regulatory guidance such as ICH, USP/EP/JP, applicable to analytical...designing method transfer and validation studies per ICH and FDA guidelines is highly desired. + Prior experience with… more
    ThermoFisher Scientific (06/28/25)
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  • Account Executive, ES (Western PA/Western VA…

    Fujifilm (Boston, MA)
    …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... achieving a 10% annual increase of market share. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
    Fujifilm (08/15/25)
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  • ENDOSCOPY Clinical Specialist or Advanced GI…

    Fujifilm (Boston, MA)
    …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... resource for the Company and its sales team. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world,… more
    Fujifilm (08/09/25)
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  • Specialist, Clinical Apps - MRI

    Fujifilm (Boston, MA)
    …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... operation of Fujifilm Magnetic Resonance Imaging Products. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a… more
    Fujifilm (07/02/25)
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  • Technician, Installation (Mechanical)

    Fujifilm (Boston, MA)
    …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... new/existing super-conductive MRI systems at customer sites. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a… more
    Fujifilm (06/01/25)
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  • Quality Systems Manager

    Biomat USA, Inc. (Worcester, MA)
    Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. . Maintains oversight of center training program… more
    Biomat USA, Inc. (07/18/25)
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  • Senior Clinical Research Director, I&I

    Sanofi Group (Cambridge, MA)
    **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company ... submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China...for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the… more
    Sanofi Group (07/06/25)
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  • Legal Counsel, Americas

    Danaher Corporation (Waltham, MA)
    …requirements and stay aligned with relevant laws and regulations, including healthcare compliance (eg, Anti-Kickback Statute), FDA regulations, anti-corruption ... This role provides legal guidance on a wide range of commercial, compliance, and regulatory matters, with a particular focus on Latin America. The Legal Counsel will… more
    Danaher Corporation (07/03/25)
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  • Mgr. Business Analyst, In-Vivo & Non-Clinical…

    Bristol Myers Squibb (Cambridge, MA)
    …Characteristics: + Strong commitment to a career in technology with a passion for healthcare . + Proven experience with LIMS and ELN systems. + Degree in Biological ... meet the identified requirements, ensuring alignment with best practices and regulatory standards. + Support: Support end users with configuration, customization,… more
    Bristol Myers Squibb (08/22/25)
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  • Associate Medical Director, Pharmacovigilance…

    Sumitomo Pharma (Boston, MA)
    …and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
    Sumitomo Pharma (08/15/25)
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