- Astrix Technology (Irvine, CA)
- …System policies and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies pertaining ... Science + Years' Experience: 0-1 years + Familiarity with regulatory reporting requirements for medical devices (eg MDRs, Vigilance...device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803… more
- Abbott (Pleasanton, CA)
- …postmortems, driving continuous improvement. + **Compliance & Security** : Ensure systems meet regulatory standards (eg, HIPAA, FDA CFR Part 11, ISO 13485). + ... As a Senior SRE, you'll work closely with engineering, QA, cybersecurity, and regulatory teams to ensure our systems meet the highest standards of availability,… more
- Actalent (San Clemente, CA)
- …+ Proven track record in gap analysis, risk assessment, and remediation planning for regulatory audits or submissions. + Familiarity with FDA , EU MDR, and other ... identifying compliance gaps, and developing remediation strategies to ensure regulatory readiness and patient safety. Responsibilities + Validate intended device… more
- Edwards Lifesciences (Irvine, CA)
- …+ Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA , ISO) for pharma/medical devices + Excellent ... the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …systems and leading cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS ... end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ Interest in clinical trial compliance + Interest in learning about audits and regulatory authority inspections (eg FDA , EMA, etc.) + Interest in learning about ... plan, and effectiveness check management and execution + Assisting in Regulatory Authority inspection readiness and preparation activities + Assisting in managing… more
- BrightSpring Health Services (Cypress, CA)
- …of practice + Knowledge of drug therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA ). + Proficiency in electronic medical ... medications and biologicals. + Ensure compliance with all state and federal regulatory requirements related to pharmacy practice and medication management. + Report… more
- Unilever (San Francisco, CA)
- …degree in food science, Chemistry, or related science field + Familiarity with FDA guidelines for dietary supplementation and regulatory processes + Familiarity ... of vitamins and dietary supplement formulation, assessing stability data and risks, regulatory standings, and assessing clinical studies + Ability to execute daily… more
- Cedars-Sinai (West Hollywood, CA)
- …fields and functional units, and computer application experience. + Knowledge of regulatory requirements including Federal, FDA , State, and standards set by ... specialized equipment and machinery. + Ensures all activities align with regulatory guidelines and safety standards, as appropriate. Interacts with core laboratory… more
- Medtronic (Northridge, CA)
- …Application/Product lifecycle management, Quality management, CAPA, Complaints handling. + Ensure regulatory readiness and support FDA audits by maintaining ... a process, data and technology roadmap across the R&D, Quality and Regulatory Systems value chain. + Champion digital transformation initiatives and global cloud… more