- Caldera Medical (Westlake Village, CA)
- …managing Corrective and Preventive Action (CAPA) activities to ensure compliance with FDA , ISO, and other applicable regulatory requirements. The ideal candidate ... complaint evaluations, including medical device reporting (MDR) or equivalent regulatory submissions. * Collaborate with cross-functional teams ( Quality ,… more
- Abbott (Pleasanton, CA)
- …with quality . You will work closely with cross-functional peers in quality , operation, marketing, clinical and regulatory , medical affairs, commercials to ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Abbott (Sylmar, CA)
- …regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating ... Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other … more
- Cedars-Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and Responsibilities + ... meetings. + Notifies direct supervisor about concerns regarding data quality and study conduct. + Works closely with a... and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board… more
- Edwards Lifesciences (San Diego, CA)
- …evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help ... Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of...and EU MDR for clinical evaluations. + Familiarity with FDA PMA applications. + Good knowledge of scientific research… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and Responsibilities + ... meetings. + Notifies direct supervisor about concerns regarding data quality and study conduct. + Works closely with a... and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board… more
- Stanford Health Care (Palo Alto, CA)
- …of a team that is transforming cancer care while being committed to the quality of the patient experience. SWCC provides comprehensive care to women from the time ... Physician Assistants with oncology expertise and a commitment to quality and patient centered care. **This is a Stanford...Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved… more
- Stanford Health Care (Redwood City, CA)
- …of this role will be on Total joints, sports, and acute injury cases, providing high quality care to our patients. As a Per Diem Orthopedic App, you will work 3-5 ... ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and licensure… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project ... Escalates to senior leadership as needed . Partners with Quality Assurance to resolve quality -related issues with...co-meds for clinical studies . Mature knowledge of the FDA , cGMP, GCP standards and regulatory guidance… more
- Abbott (Pleasanton, CA)
- …to drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA , ISO 13485). + **Develop and manage detailed ... qualifications** , ensuring documentation and processes meet internal and external regulatory requirements. + **Collaborate with engineering, quality , and… more