- Sutter Health (San Francisco, CA)
- …* Protects patients and technicians by adhering to infection-control protocols. COMPLIANCE * Maintains strictest confidence of all patients Protected Health ... Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written and verbal… more
- Genentech (South San Francisco, CA)
- …for impactful outcomes. + Substantive understanding of corporate legal and compliance , including GCP, OIG guidelines, US Regulatory/ FDA requirements, and ... drug access. **Preferred Qualifications & Experience** + 2 or more years' clinical experience or equivalent experience + Extensive project management experience **Location** The position is located in South San Francisco. The expected salary range for this… more
- Roche (Carlsbad, CA)
- …Oversee and maintain manufacturing, laboratory, and R&D equipment to ensure compliance with manufacturers' specifications and regulatory requirements. + Jobs as ... required + Asset Database Management system experience required Preferred experience: + FDA , cGMPs, and/or ISO knowledge a plus + Experience with automated liquid… more
- Roche (Carlsbad, CA)
- …software for a medical device and software tools for internal teams, ensuring compliance with regulatory standards (eg, FDA , ISO, IEC). The Engineer will ... collaborate with cross-functional teams, including hardware engineers, quality assurance, and clinical experts, to define software requirements and specifications. In addition, the Engineer will be expected to troubleshoot and resolve complex software issues… more
- Actalent (Irvine, CA)
- …issues as needed. + Review and spot-check deliverables to ensure quality and compliance . Essential Skills + Proven ability to analyze and resolve complex process and ... Medical device industry experience is required, with a deep understanding of FDA regulations, ISO standards, and global quality systems. Additional Skills &… more
- Fujifilm (Sacramento, CA)
- …creation and maintenance of all relevant documentation required for the purposes of compliance with applicable regulations. + Assign and track work of team members. ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Abbott (Alameda, CA)
- …including Commercial Payors, Pharmacy and Medical Benefit structures, CMS and FDA guidelines to inform strategic contracting decisions. + Translate pricing ... + Accomplished and skillful in execution. + Strong financial acumen, including compliance + Excellent verbal and written communication skills + Effective leadership… more
- Genentech (South San Francisco, CA)
- …and outcomes across the portfolio, enabling accountability, performance visibility, compliance , and continuous improvement. You will provide regular progress updates ... research; Familiarity with global regulatory frameworks and global research expectations (eg, FDA , EMA, ICH). + You have a demonstrated record of external engagement… more
- Sutter Health (Berkeley, CA)
- …on and new medications that were started in the hospital, evaluates patient compliance with new drug regimens, and follows-up with the patient regarding side effects ... Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Experience with Epic electronic… more
- J&J Family of Companies (Santa Clara, CA)
- …on cybersecurity and AI/ML requirements, oversee implementation, and ensure compliance . + Drive root cause analysis and corrective/preventive actions (CAPA) ... problem solving, and analytical skills + Working knowledge of IEC 62304, FDA 's General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR… more