• Document Control Specialist

    Integra LifeSciences (Braintree, MA)
    …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 ... implement process-level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. + Maintains… more
    Integra LifeSciences (07/16/25)
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  • Sr. Director, Product Development

    J&J Family of Companies (Danvers, MA)
    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, ... we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact… more
    J&J Family of Companies (08/16/25)
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  • Principal Quality Assurance Engineer

    Hologic (Marlborough, MA)
    …about mentoring leaders, solving complex challenges, and shaping the future of healthcare quality, we want to hear from you! **Knowledge:** + In-depth understanding ... of FDA Quality System Regulations, ISO 13485, and Medical Device...Medical Device Directive. + Expertise in compliance issues and regulatory expectations. + Advanced knowledge of Quality Management Systems… more
    Hologic (08/26/25)
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  • Manager, PVRM

    Sumitomo Pharma (Boston, MA)
    …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
    Sumitomo Pharma (08/01/25)
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  • QC Manager, Bioanalytical

    ThermoFisher Scientific (Plainville, MA)
    …2-3 years experience leading teams in a fast-paced environment required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other ... and drive efficiency throughout the organization. + Support internal, external, and regulatory inspections as needed. + Hire and develop employees within the… more
    ThermoFisher Scientific (06/26/25)
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  • Business Development Mgr, ESD (East Coast)

    Fujifilm (Boston, MA)
    …States. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... changes, post-market surveillance, and product obsolescence. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a… more
    Fujifilm (07/24/25)
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  • Cell Therapy Coordinator

    Dana-Farber Cancer Institute (Boston, MA)
    …Requiring an ability to learn and work within multiple sets of regulatory compliance requirements, and performing complex decision tree procedures in more advanced ... is performed within standards as established by FACT, the FDA , NMDP, and JC, and the specific protocol under...is responsible for carrying out specialized tasks to support regulatory requirements and patient safety, requiring an understanding of… more
    Dana-Farber Cancer Institute (08/28/25)
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  • Data Scientist

    Takeda Pharmaceuticals (Boston, MA)
    …structured and unstructured datasets from clinical trials, real-world evidence (RWE), and regulatory databases (eg, FDA ), utilizing SQL and performing version ... deployment on platforms like AWS; demonstrate expertise with pharmaceutical and healthcare datasets, including real-world data (RWD), clinical trial data, and drug… more
    Takeda Pharmaceuticals (08/23/25)
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  • Sales Specialist, Diagnostic Oncology (Central…

    Fujifilm (Boston, MA)
    …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... well as clinical performance and utility of assays. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
    Fujifilm (08/14/25)
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  • Quality Assurance Engineer 1

    Teleflex (Mansfield, MA)
    …quality and reliability. 2. Assists in ensuring the manufacturing processes comply with regulatory and quality system standards, including FDA , ISO 13485, and ... of people's lives. Through our vision to become the most trusted partner in healthcare , we offer a diverse portfolio with solutions in the therapy areas of… more
    Teleflex (08/23/25)
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