• Sr. Director, Design and Supplier Quality

    Candela Corporation (Marlborough, MA)
    …quality / regulatory / compliance. . Working understanding of relevant global /regional medical device regulations and standards with particular emphasis on ... improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively… more
    Candela Corporation (09/30/25)
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  • Senior Manager, Clinical Operations

    ConvaTec (Lexington, MA)
    …8 to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company. + Solid ... understanding of the device development process, ICH guidelines/GCP and specifically, each step...(Study Management, Site Management, Data Management / Data Analytics), Global Head of Clinical Operations, R&D, Regulatory more
    ConvaTec (09/19/25)
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  • Clinical Project Manager 4

    Hologic (Marlborough, MA)
    …the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to ... leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, and with… more
    Hologic (10/16/25)
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  • Program Manager, RST RPE PMO

    Medtronic (Boston, MA)
    …prioritization. * Collaborate with Verification & Validation, Systems Engineering, and Regulatory Affairs to ensure appropriate test coverage and documentation. ... role, you'll lead a dynamic team, collaborating across departments like R&D, Quality Affairs , and Marketing to spearhead a series of successful RPE project release.… more
    Medtronic (11/04/25)
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  • Director, Quality Systems

    Olympus Corporation of the Americas (Westborough, MA)
    …and governance supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the ... improve Olympus compliance profile. + Monitors plans and applies Global regulatory or Olympus requirements into the...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs more
    Olympus Corporation of the Americas (11/15/25)
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  • Lead Design Assurance Engineer

    Hologic (Marlborough, MA)
    …product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs , and Manufacturing Engineering teams to embed quality and compliance ... planning, and requirements traceability. + Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices. + Proficiency in… more
    Hologic (10/30/25)
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  • Lead Design Assurance Engineer

    Hologic (Marlborough, MA)
    …role in new product development, ensuring that design controls, risk management, and global regulatory compliance are maintained from concept to product launch. ... compliance. + Collaborative and team-oriented, building strong relationships across R&D, Regulatory Affairs , Manufacturing, and other key stakeholders. +… more
    Hologic (10/30/25)
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  • Software Manager - Surgical Robotics

    Medtronic (Boston, MA)
    …Collaborate cross-functionally with software development, systems engineering, quality assurance, and regulatory affairs teams to ensure seamless integration and ... practices, test automation strategies, and emerging technologies relevant to medical device software. + Champion and implement Lean-Scaled Agile Framework (SAFe)… more
    Medtronic (10/23/25)
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  • Program Manager, Real-World Evidence (Remote)

    Stryker (Boston, MA)
    …+ A basic understanding of the clinical evidence needs in the global regulatory environment for clinical investigation, clinical evaluation, post-market clinical ... studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs , Regulatory , HEOR, and Commercial + Ensure scientific rigor and… more
    Stryker (11/07/25)
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  • Lead Counsel, Market Access, Oncology

    Takeda Pharmaceuticals (Cambridge, MA)
    …products within the US Market. You will report to the Head Counsel, Takeda Global Oncology, and you will work very closely with your Oncology Business Unit Clients. ... payers, pharmacy benefit managers (PBMs), Oncology GPOs, the Department of Veterans Affairs (VA), Federal Supply Schedule (FSS), Medicaid, the Department of Defense… more
    Takeda Pharmaceuticals (10/23/25)
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