• Director, Quality Systems

    Olympus Corporation of the Americas (Westborough, MA)
    …21 CFR 820 and ISO 13485 required. + Working knowledge of international medical device quality system requirements required. + Complete understanding and ... and early morning teleconferences. **Preferred:** + MBA Preferred. + Medical Device Experience preferred + Black Belt...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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  • Sr. Software Quality Engineer

    Medtronic (Newton, MA)
    …live case learning opportunities. + Collaborate with cross-functional teams, including R&D, regulatory affairs , and clinical teams, to ensure alignment on ... written and oral communication skills. + 2+ years of medical device or other regulated industry (such...a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or… more
    Medtronic (11/08/25)
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  • Sr. Director, Design and Supplier Quality

    Candela Corporation (Marlborough, MA)
    …improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively ... field, plus 15 years of related experience in the medical device industry with at least 12...12 years in a management/leadership role in quality / regulatory / compliance. . Working understanding of relevant global/regional… more
    Candela Corporation (09/30/25)
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  • Senior Engineer - Algorithms and Signal Processing

    ZOLL Medical Corporation (Chelmsford, MA)
    …provide innovative technologies that make a meaningful difference in people's lives. Our medical devices , software and related services are used worldwide to ... team and with cross-functional team members in scientific and clinical affairs , product development, regulatory , quality, and manufacturing. Essential Functions:… more
    ZOLL Medical Corporation (10/02/25)
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  • Director, Quantitative Clinical Pharmacology Lead

    Takeda Pharmaceuticals (Cambridge, MA)
    …Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/ Device , and Global Regulatory Affairs . + ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or… more
    Takeda Pharmaceuticals (09/25/25)
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  • Principal Solutions Analyst, Global IT Quality…

    Hologic (Marlborough, MA)
    …Services globally. You will collaborate with key stakeholders, including Regulatory Affairs , Quality Assurance, Supplier Quality Assurance, Engineering ... Analyst, Global IT Quality Solutions** to join our **Quality, Regulatory , and Product Life Cycle Management Systems Center of...managing and supporting Quality systems. + Experience in the medical device or regulated industries is highly… more
    Hologic (09/13/25)
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  • Lead Counsel, Market Access, Oncology

    Takeda Pharmaceuticals (Cambridge, MA)
    …payers, pharmacy benefit managers (PBMs), Oncology GPOs, the Department of Veterans Affairs (VA), Federal Supply Schedule (FSS), Medicaid, the Department of Defense ... as counsel for our Government Price Reporting function concerning legal, regulatory , and compliance issues associated with federal government price reporting… more
    Takeda Pharmaceuticals (10/23/25)
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  • CMC Project Manager

    Takeda Pharmaceuticals (Boston, MA)
    …+ Co-leads CMC teams with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor ... & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process. + knowledge, capability & improvement,… more
    Takeda Pharmaceuticals (10/10/25)
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  • Quality Assurance Coordinator

    Danaher Corporation (Waltham, MA)
    …position reports to the Quality Assurance Manager and is part of the Regulatory Affairs and Quality Assurance department located in Waltham Massachusetts and ... systems. + 2 years' experience of working within the Life Science or Medical Device Industry. + A working knowledge of quality systems such as ISO 9001:2015… more
    Danaher Corporation (11/18/25)
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  • Manager, Packaging Development

    J&J Family of Companies (Raynham, MA)
    …audits) are consistent, robust, appropriate, and timely. + Partners with Regulatory Affairs , Compliance, and Packaging/Labeling PMOs to ensure all ... Skills:** **Required:** + Organization and Talent Development is required. + Medical Device knowledge is required. + Experience partnering across geographies and… more
    J&J Family of Companies (11/15/25)
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