• Quality Engineer II - Design & Reliability…

    Integra LifeSciences (Braintree, MA)
    …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... you to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every… more
    Integra LifeSciences (06/07/25)
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  • Sr. Manufacturing Quality Engineer I

    Integra LifeSciences (Braintree, MA)
    …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position ... work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To...such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with sterility… more
    Integra LifeSciences (06/06/25)
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  • Senior Scientist: IVD Assay Developer

    Nanobiosym, Inc. (Cambridge, MA)
    …+ Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission + Manage and contribute to regulatory documents + Project ... leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer...+ Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated… more
    Nanobiosym, Inc. (06/05/25)
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  • Lead Project Engineer

    Fujifilm (Boston, MA)
    …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to working in highly dynamic multi-vendor environment and stay up-to- date on healthcare and general IT trends, best practices, regulations, and a wide range of… more
    Fujifilm (08/13/25)
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  • Assistant General Counsel - At-Home Solutions

    Cardinal Health (Boston, MA)
    …Cardinal Health is seeking a driven and skilled attorney with expertise in healthcare regulatory compliance, including third party billing and reimbursement. The ... for business clients. * Proactively develop and remain up-to-date on healthcare regulatory matters impacting the business, including current regulations,… more
    Cardinal Health (08/16/25)
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  • Lead, Contamination Control & Sterility Assurance

    Sanofi Group (Framingham, MA)
    …Assurance** **Location:** Framingham, MA **About the job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and ... during microbial investigations and product impact assessments. We are an innovative global healthcare company with one purpose: to chase the miracles of science to… more
    Sanofi Group (08/27/25)
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  • Team Lead Quality Drug Product Operations

    Sanofi Group (Framingham, MA)
    …Operations** **Location:** Framingham, MA **About the job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and ... DP release for CIM. We are an innovative global healthcare company with one purpose: to chase the miracles...etc.), quality agreements, and audits + Knowledgeable on current regulatory guidance or requirements (ie, ICH Q9, Annex 3,… more
    Sanofi Group (08/27/25)
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  • Head of Engineering & Projects

    Sanofi Group (Framingham, MA)
    …& Projects **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and ... patients and their families. We are an innovative global healthcare company with one purpose: to chase the miracles...and external audits and inspections + Interface with external regulatory agencies as required. + Ensure and maintain harmonized… more
    Sanofi Group (08/20/25)
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  • Donor Search Specialist, Stem Cell Transplant…

    Dana-Farber Cancer Institute (Boston, MA)
    …donor status including progress, challenges, and adjustments. + Ensure compliance with all regulatory bodies (eg, FDA , AABB, FACT, NMDP) related to donor ... logistical, and administrative aspects of donor services, ensuring compliance with regulatory standards and supporting overall operations of the Cellular Therapy… more
    Dana-Farber Cancer Institute (07/17/25)
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  • Sr. Engineering Manager

    Abbott (Westford, MA)
    …work environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Abbott is a global healthcare leader that helps people live more fully...of engineering systems and procedures to ensure compliance to FDA , GMP, and all other applicable agency regulations. +… more
    Abbott (08/23/25)
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