- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Ensure compliance with regulatory standards relevant to medical devices (eg, FDA , EMA, PMDA), quality systems/SOPs, data integrity and audit readiness. + ... they are completed on time, within budget, and in compliance with regulatory guidelines. + Design statistical analysis plans for clinical studies and observational… more
- Stanford Health Care (Palo Alto, CA)
- …ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and licensure ... Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -...of community resources. + 16. Ensures compliance with legal, regulatory and clinical policies and procedures. + 17. Participates… more
- Caris Life Sciences (Tempe, AZ)
- …trial master files. + Contribute to and/or lead process improvements. + Socialize regulatory requirements and standards (eg, FDA , ICH GCP, ISO 20916, IVDR, ... Companion Diagnostics Specialist will collaborate with Clinical Research, QA, Regulatory Affairs and other study stakeholders to coordinate study-related activities… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... providers and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. + Participates in quality … more
- GRAIL (Durham, NC)
- …lifecycle, from sample ingestion through analysis, ensuring every step meets rigorous regulatory and clinical standards. We are seeking a Staff Software Engineer to ... help deliver the high- quality datasets that power research, analytics, and scientific insights....cross-functional teams to deliver scalable data solutions aligned with FDA and global health authority requirements. Our ideal candidate… more
- Stony Brook University (Stony Brook, NY)
- …the Respiratory Care Department. They must also perform and understand all quality control procedures, review the accuracy of final test reports, recognize routine ... analyzers and maintains consumable supplies. * Performs and understands all quality control procedures as required by departmental protocols. Identifies and insures… more
- Terumo Medical Corporation (Elkton, MD)
- …and validates new or modified manufacturing processes in compliance with TMC Quality System requirements and regulatory standards. + Applies advanced engineering ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- BeOne Medicines (San Mateo, CA)
- …with cross functional leaders/stakeholders (eg Clinical Development, Data Management, Quality , Regulatory ) as it relates to planning, interdependencies, ... , or compliance roles)** **ICH GCP subject matter expert** **Knowledgeable of regulatory requirements (eg, FDA , MHRA/EMA)** **Experience working in a… more
- ITG Brands (Greensboro, NC)
- …standards, and best practices guiding product manufacturing, packaging, safety, and quality presenting a clear, focused concept for strategic consideration. This ... and Product data management + Manages and maintains material/product regulatory compliance documentation in central specification system ensuring record completion… more
- Terumo Medical Corporation (Caguas, PR)
- …diagrams, and technical documentation. + Familiarity with industrial safety standards and regulatory requirements (eg, FDA , ISO, OSHA). + CMMS proficiency and ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
