- BeOne Medicines (San Mateo, CA)
- …a relevant field such as Quality Assurance, Supply Chain (commercial and/or clinical ), Manufacturing, Regulatory Compliance , Clinical Development or ... and drive the compliance activities within Global Clinical Operations. Provides quality guidance, direction and...aptitude to learn about the evolving the legal and regulatory environment, GMP and GDP, applicable laws, regulations and… more
- Gilead Sciences, Inc. (Foster City, CA)
- … strategy and associated capabilities to support the CDS objectives + Manage quality review of clinical trial documents, workflows, and outputs within the ... CDS organization to ensure clinical trials are conducted in compliance with...audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections,… more
- BeOne Medicines (Emeryville, CA)
- …areas such as CMC, Reg Strategy, Clinical /Non- Clinical , Quality /Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance . This position ... within Regulatory Affairs and functional organizations including partnering with Quality (GxP Systems) and IT business partners to ensure effective communication… more
- Terumo Neuro (Aliso Viejo, CA)
- …and guidelines applicable to the medical device industry to contribute to overall quality and regulatory compliance objectives. Encompass a broad spectrum ... Quality Assurance **Job Description:** Provide support to all aspects of the Clinical Quality Assurance (CQA) function across the business. Support CQA… more
- 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
- Caldera Medical (Westlake Village, CA)
- … licensing by jurisdictions. * Work cross-functionally with R&D, Quality , Clinical , and Marketing teams to ensure regulatory requirements are met throughout ... submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU… more
- Bausch + Lomb (Sacramento, CA)
- …operational excellence, compliance , and timely execution of deliverables. + Drive regulatory strategies for clinical , non- clinical , CMC and labeling ... adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance , influencing key stakeholders, and optimizing business outcomes.… more
- Stanford University (Stanford, CA)
- …a strong team of regulatory experts responsible for the administration and regulatory compliance of clinical research within the university, and ... communication skills, teamwork, and superb attention to detail. We strive for top- quality regulatory support of investigator-initiated clinical trials with… more
- Merck (San Diego, CA)
- … Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical ... and follow-up of regulatory applications and ensure quality and compliance across all documentation. +...content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory … more
- Abbott (Sylmar, CA)
- …mentor regulatory professionals **Premarket:** + Assess the acceptability of quality , preclinical and clinical documentation for submission filing + Compile, ... requirements + Review and approve advertising and promotional items to ensure regulatory compliance + Ensure external communications meet regulations + Develop,… more