- Terumo Neuro (Aliso Viejo, CA)
- …met and consistent. + Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and ... and developing and/or enhancing data management processes to ensure complete, accurate, high quality clinical data and adhering to Good Clinical Practices and FDA… more
- Abbott (Plymouth, MN)
- …or modified, are distributed to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the ... and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory agencies. + Acts as liaison between the Company and… more
- Insight Global (Rochester, MN)
- …is seeking a contracted Regulatory Specialist to support the Vice President of Quality Assurance and Regulatory Affairs. The contractor will focus on the execution ... of regulatory documentation, submissions, and compliance tasks to ensure timely delivery of project milestones....hands-on experience in EU MDR and working knowledge of FDA , Health Canada, and Japan PMDA requirements. Scope of… more
- Candela Corporation (Marlborough, MA)
- …Reliability and maintainability trends . Operate Sustaining Engineering activities in an FDA regulated environment that meets internal quality requirements and ... team interfacing with Marketing (GBU), Clinical, Service, Manufacturing, Regulatory, and Quality organizations when needed . **Essential Job Functions** . Manage a… more
- Lilly (Indianapolis, IN)
- …Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization. ** Compliance & Documentation** : + ... visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance...Ensure compliance with FDA and any other global applicable regulatory standards by… more
- Actalent (Hazelwood, MO)
- …Title: QA Specialist Job Description The QA Specialist is responsible for ensuring compliance with all regulations and quality systems within our international ... Develop and implement departmental operational procedures to ensure regulatory compliance with FDA , GMP, ISO, and OSHA...to the department. + Lead activities contributing to QMS compliance , including CAPA, change control, supplier quality ,… more
- Mount Sinai Health System (New York, NY)
- …resources and allocate tasks to ensure timelines and objectives are met. **Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere to Good ... study management. + Develop and implement best practices to enhance efficiency, data quality , and compliance . + Monitor industry trends and integrate innovative… more
- Vera Therapeutics (Brisbane, CA)
- …solutions, cost sheets, etc. Compliance & Regulatory Oversight * Ensure full compliance with FDA , EMA, GMP, GCP, GDP, and SOX regulations across all ... a strong focus on vendor selection and performance management, regulatory compliance , risk mitigation, contract oversight & management and operational excellence.… more
- University of Miami (Miami, FL)
- …this position ensures efficient and effective departmental operations, including department quality control and compliance adherence. The Manager, Medical ... Technologists provides leadership and management for clinical laboratory procedures, quality assurance, and instrument maintenance. The Manager, Medical Technologists… more
- J&J Family of Companies (Athens, GA)
- …specifications and in accordance with standard operating procedures, as regulated by quality , environmental, and safety agencies ( FDA , EPA, OSHA, DEA, etc.). ... Our Credo stakeholders first, pursuing the highest standards of compliance , quality and ethics. + Connect inclusively...with all state and federal regulations and guidelines including FDA , EPA, OSHA and DEA. Maintain compliance … more