- Amazon (San Francisco, CA)
- Description We are seeking an experienced Clinical Quality Manager for Senior Health to join Amazon One Medical. Reporting directly to the National Leader for ... Clinical Quality , this role will be responsible...Clinical Quality , this role will be responsible for ...measures and develop workflows to support measurement and improvement. Regulatory Compliance & Vendor Management - Ensure… more
- Sanofi Group (Morristown, NJ)
- …active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase ... regional labeling (eg, US Prescribing Information, EU SmPC) comply with global regulatory requirements, reflect current scientific and clinical evidence, and… more
- System One (Florham Park, NJ)
- …documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, ... review of published submissions to ensure consistency and compliance with regulatory requirements. + Perform quality control checks on documents to ensure… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... 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… more
- Globus Medical, Inc. (Audubon, PA)
- …needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine ... 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… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …execute pre-approval compliance activities. + Assess the acceptability of quality , preclinical and clinical documentation for submission filing. + Negotiate ... policy. + Review and approve advertising and promotional items to ensure regulatory compliance . + Assess external communications relative to regulations. +… more
- Philips (Plymouth, MN)
- …to ensure an effective Quality System is maintained. Providing regulatory support for (pre-) clinical studies, including recommending strategies to ... Ultrasound Products meet FDA, and other governmental agency/notified body Regulatory Compliance standards/requirements. **Your Role:** + Leads business… more
- Merck (Rahway, NJ)
- …preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with ... seamless communication and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network… more
- Hartford HealthCare (Farmington, CT)
- …regulation, policy, and guideline changes to appropriate stakeholders. . Participates in Clinical Quality Council meetings, represents CDI at local and system ... and manages an effective and comprehensive Health Information Management (HIM) Clinical Documentation Integrity (CDI) quality , audit, education, and denials… more
- Dignity Health (Santa Cruz, CA)
- …support key initiatives, including but not limited to, activities focused on clinical quality improvement, patient safety and risk reduction, patient experience, ... **JOB SUMMARY / PURPOSE** The primary function of the Quality /Patient Safety Program Manager Clinical License is...in order to improve management of outcomes and ensure compliance . + Assists with regulatory readiness and… more