- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... on regulatory strategy documents Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing divisions Work with… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Catalent (Philadelphia, PA)
- …for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to ... over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel,… more
- DivIHN Integration Inc (Green Oaks, IL)
- …(GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling ; Domestic and international regulatory guidelines, policies and ... Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7...creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Main purpose of… more
- DivIHN Integration Inc (North Chicago, IL)
- … labeling , appropriate regulations and interpretations. Partner with other regulatory functions for smooth project transition and launch. Support review of ... Specialists Meghna at ### Rashi at ### Title: Specialist Regulatory Affairs Duration: 7 Months Location: Abbott Park, IL/...creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Accountability / Scope:… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …examination of clinical evidence and provide input to risk assessment and product labeling as well as clinical / regulatory strategiesStay current on clinical ... Overview We are hiring a Clinical Affairs Program Manager . The Clinical Affairs Program Manager ...of Conformity and EU market clearance, recertification and proposed indication/ labeling changes, as well as CER updates to maintain… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …the QC Bioassay/Virology team and managing day‐to‐day activities of team. The Manager represents QC Bioassay/Virology during customer and regulatory audits. The ... it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs,… more
- Rose International (Temecula, CA)
- …an understanding of their impact on the systems environment. Responsibilities: * Labeling workstream project manager responsible for coordinating the creation, ... Rose International Position Number: 462447 Job Title: Associate Project Manager Job Location: Temecula, CA, USA, 92591 Work Model:...approval and release of labeling . * Identify, develop, and gather resources to complete… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …of raw materials and excipients, represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids ... will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in...Carolina, United States. External US About This Role The Manager , QC Raw Materials Manager is accountable… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... information, please visit healthcaresolutions-us.fujifilm.com. External US Job Title: Product Manager , MKTJob purposeThe Product Manager is responsible for being… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... information, please visit healthcaresolutions-us.fujifilm.com. External US Job Title: Security Risk Manager Job purposeThe Security Risk Manager will report to… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... please visit healthcaresolutions-us.fujifilm.com. External US Job Title: Government Account Manager (GAM)Job purposeThe Government Account Manager will be… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... healthcare professionals, sales & field personnel, global R&D, operations, regulatory , global marketing, infection control, other companies/device manufacturers, etc.)… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... information, please visit healthcaresolutions-us.fujifilm.com. External US National Business Development Manager , ESDJob purposeThe primary responsibility of the National Endosurgical… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... all applicable S. Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable… more
- DivIHN Integration Inc (Alameda, CA)
- …CA Duration: 12 Months Job Description (Expectation) Responsible for regulatory activities, including product registrations, impact assessment, etc. Understand ... deliver those to internal stakeholders, including product management, engineering, labeling , etc., for product registration and change planning. Communicate weekly… more
- Southeast Georgia Health System (Brunswick, GA)
- …in diagnosis and treatment of disease. Participating in compliance of accreditation and regulatory standards (CAP, CLIA 88, GDHR) which relate to all areas of the ... laboratory's policies. Following the laboratory's procedures for specimen collection, labeling handling, transport and processing. Performing instrument and procedural… more
- Southeast Georgia Health System (St. Marys, GA)
- …in diagnosis and treatment of disease. Participating in compliance of accreditation and regulatory standards (CAP, CLIA 88, GDHR) which relate to all areas of the ... laboratory's policies. Following the laboratory's procedures for specimen collection, labeling handling, transport and processing. Performing instrument and procedural… more
- FUJIFILM Holdings America Corporation (Atlanta, GA)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... in Subject Matter Expert (SME) program.Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- FUJIFILM Holdings America Corporation (New York, NY)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... of technical support, as directed by the Area Service Manager .Location: This geography will cover all 5 New York...US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
