• Manager, Quality Assurance & Regulatory

    Tecomet (Wilmington, MA)
    …Serve as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR ... and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This... governance + Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market… more
    Tecomet (09/03/25)
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  • Engineer, IT Compliance , Lab and Quality…

    Bristol Myers Squibb (Devens, MA)
    …and Good Documentation Practices. + Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the ... configurations, data integrity, cyber security, and defends their work before regulatory agencies. + Ensures alignment with BMS directives and industry guidelines… more
    Bristol Myers Squibb (08/24/25)
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  • Project Manager - GxP-Regulated Systems (Life…

    CGI Technologies and Solutions, Inc. (Boston, MA)
    …(QMS) highly preferred (Veeva QMS or TrackWise a plus). * Solid understanding of regulatory requirements and compliance standards ( FDA , EMA, etc.). * ... candidate will lead multiple workstreams, drive agile project delivery, and ensure compliance with regulatory standards. This role requires hands-on experience… more
    CGI Technologies and Solutions, Inc. (08/28/25)
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  • Sr. Regulatory Specialist - Clinical…

    Beth Israel Lahey Health (Boston, MA)
    …just taking a job, you're making a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth ... deviations and submission of other study documents to support regulatory compliance . Troubleshoot processes and procedures when.... Preparation and submission of annual reports to the FDA . Submission of regulatory documents to NIH/OBA… more
    Beth Israel Lahey Health (08/21/25)
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  • Regulatory Coordinator - Breast Oncology

    Dana-Farber Cancer Institute (Boston, MA)
    …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... work with amazing partners, including other Harvard Medical School-affiliated hospitals. ** Regulatory Compliance ** + Prepares and submits all protocol… more
    Dana-Farber Cancer Institute (08/27/25)
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  • Principal Regulatory Affairs Specialist

    Philips (Cambridge, MA)
    …Products meet FDA , and other governmental agency/notified body Regulatory Compliance standards/requirements. **Your Role:** + Leads business critical ... protocols. + Providing guidance on current, new and updated Regulatory compliance procedures globally, such as CE...and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA 's guidance documents, and including… more
    Philips (09/04/25)
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  • Associate Director, Global Regulatory…

    Takeda Pharmaceuticals (Boston, MA)
    …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + ... maintain compliance for products. + Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. + Participates with… more
    Takeda Pharmaceuticals (08/08/25)
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  • Veeva QMS Validation and QA Lead

    CGI Technologies and Solutions, Inc. (Burlington, MA)
    …and QA activities for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements ( FDA , EMA, etc.). ... be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This role requires a… more
    CGI Technologies and Solutions, Inc. (08/20/25)
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  • Senior Director, Global Regulatory Lead, GI…

    Takeda Pharmaceuticals (Boston, MA)
    …the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in… more
    Takeda Pharmaceuticals (08/20/25)
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  • Senior Regulatory Affairs Specialist

    Philips (Cambridge, MA)
    …recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and ... Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA , EU and other worldwide government… more
    Philips (08/29/25)
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