• Senior Software Engineer

    Globus Medical, Inc. (Methuen, MA)
    …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... Functions:** + Developing prototypes, proofs of concept in addition to production- quality solutions + Ensuring efficient performance and scalability of solutions +… more
    Globus Medical, Inc. (07/11/25)
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  • QC Manager, Bioanalytical

    ThermoFisher Scientific (Plainville, MA)
    …and otherwise untreatable diseases. **Discover Impactful Work:** The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific ... & Analytics to the cGMP QC testing laboratory. The manager ensures cGMP compliance , operates within budgets, and supervises bioanalytical lab staff directly and QC… more
    ThermoFisher Scientific (06/26/25)
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  • Senior Process Architect - Life Science…

    Burns & McDonnell (Newton, MA)
    …effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry. ... experience to complex projects, and find's/develops non-standard design solutions. + Quality review production drawings for a variety of projects and project-related… more
    Burns & McDonnell (06/05/25)
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  • Research Scientist 1 - Immunochemistry

    Charles River Laboratories (Shrewsbury, MA)
    …interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include serving as ... Contributing Scientist in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct of preclinical and… more
    Charles River Laboratories (06/03/25)
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  • Manager, Biostatistics

    Sumitomo Pharma (Cambridge, MA)
    …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data...Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus… more
    Sumitomo Pharma (08/02/25)
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  • Associate Medical Director, PVRM

    Sumitomo Pharma (Boston, MA)
    …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… more
    Sumitomo Pharma (08/02/25)
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  • Principal Reg Affairs Specialist

    Medtronic (Boston, MA)
    …regulatory trends and provide guidance to internal stakeholders. Collaborate with R&D, Quality , and other teams to ensure product compliance throughout the ... Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products commercialized by Digital… more
    Medtronic (07/30/25)
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  • Senior Regulatory Affairs Specialist

    Hologic (Marlborough, MA)
    …the ongoing support, maintenance, and continuous improvement of regulatory compliance for our capital equipment medical device portfolio. Working cross-functionally ... with R&D, Quality , Clinical, and Marketing, you will prepare and manage...update labeling, marketing materials, and user manuals to ensure compliance with all applicable regulations and company policies +… more
    Hologic (07/19/25)
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  • Sr. Sterility Assurance Scientist

    Integra LifeSciences (Mansfield, MA)
    …cover sterilization programs across sites. + Obtains and maintains knowledge of FDA , ISO, and EN sterilization and related microbiology standards and guidelines, for ... 11137, ISO 11135 and environmental monitoring requirements. + Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans + Subject… more
    Integra LifeSciences (07/01/25)
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  • Senior Manager, Pharmacovigilance Scientist

    Sumitomo Pharma (Boston, MA)
    …adverse event reports-including serious cases-ensuring appropriate interpretation, consistency, and quality in both individual case and aggregate safety assessments; ... or cross-functional ad hoc projects requiring safety input, ensure regulatory and SOP compliance , and foster a "Patient First" culture in alignment with SMPA values.… more
    Sumitomo Pharma (06/28/25)
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