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Provide services to individuals according to, DDS, DMH, MassHealth, HUD, DPH, CARF, all applicable regulatory standards, and Bridgewell policies and procedures. Maintain daily and monthly progress notes, shift checklists, and other program documentation according to DDS, DMH, and all applicable regulatory standards.
$19.35 - $19.95 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position requires a strong understanding of both immunoassay development and manufacturing processes, with a focus on maintaining assay integrity, optimizing efficiency, and ensuring regulatory compliance.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Expert level knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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3+ years of experience in General Regulatory Affairs with previous experience in the preparation of IND, CTA, MAA, NDA submissions to include reviewing and/or writing sections of applications from a clinical, nonclinical, or CMC regulatory perspective.
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Provide significant regulatory inspection readiness training, coaching and guidance to junior level staff/SMEs in validation group. Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
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Serve as a technical writer to support MTD and QC organization for internal and external communications, including regulatory submissions and responses. Maintain and grow personal scientific, regulatory and compendial expertise, and work with lab management to develop organizational capabilities.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Highly knowledgeable of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Regulatory Compliance: Lead preparations for regulatory inspections and audits, complete the annual DPH survey, and ensure the facility’s long-term care license remains in good standing.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Work cross-functionally across technical operations and with the external CMO's and technical teams leveraging other functions within BMS such as process and analytical development, quality, regulatory, manufacturing and supply chain counterparts.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Support any regulatory inspections or internal/external audits. pH Meter, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Infrared (IR), Gamma Ray Spectrometer, Flame Atomic Absorption (AA), Scanning Ultraviolet/Visible (UV/VIS) Spectrometer, Polarograph, Coulometer, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography.
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Reporting to the General Counsel, the Vice President, Chief Compliance Officer (CCO) is a key member of Insulet Corporation’s Legal Department, leading the global Compliance function to ensure compliance with laws, regulatory requirements, policies, and procedures.
$354,380 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization.
$39.86 - $49.23ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities. Review calibration, monitor and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment.
$119,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Privacy Officer oversee data privacy and protection policies to ensure that the entire organization processes the personal data of their customers, employees, and partners, in accordance with company policies and regulatory compliance requirements.
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regulatory job Company: Abbott in Westford, MA
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