- Merck (San Diego, CA)
- …lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary… more
- Stanford Health Care (Redwood City, CA)
- …in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and ... Total joints, sports, and acute injury cases, providing high quality care to our patients. As a Per Diem...Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -… more
- Globus Medical, Inc. (San Diego, CA)
- …aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project… more
- Sumitomo Pharma (Sacramento, CA)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more
- Stanford Health Care (Redwood City, CA)
- …in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and ... Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label… more
- Stanford Health Care (Palo Alto, CA)
- …in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and ... Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label… more
- GRAIL (Menlo Park, CA)
- …with internal teams to implement appropriate changes. + Support internal and external quality audits. + Ensure compliance with all regulations and laws ... and other relevant documentation. The role collaborates cross-functionally with Quality , Lab Operations, and other stakeholders to support regulatory strategy… more
- J&J Family of Companies (Santa Clara, CA)
- …products being developed + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned ... processes by working closely with research/development, operations, regulatory, and quality teams. **Essential Job Functions** + Develop product(s) for manufacturing… more
- J&J Family of Companies (Santa Clara, CA)
- …and manufacturing environments (ISO, FDA , cGMP). + Knowledge of and compliance with applicable Quality System requirements (eg, traceability QSRs, ISO and ... or tooling as appropriate, troubleshooting and implementing changes to improve manufacturing quality and product performance. The Senior Engineer will assist in the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Well versed in FDA and ICH guidelines relating to registration, quality , and compliance concerning drug substance and drug product. + Proven track ... development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key… more