- Takeda Pharmaceuticals (Los Angeles, CA)
- …QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards and drive procedural ... improvements. + Support internal and external audits (eg, FDA , Corporate Quality Assessments) by ensuring compliance with procedures, guidelines, and regulatory… more
- J&J Family of Companies (Santa Clara, CA)
- …organization. + Ensure NPS systems are validated, maintained, and operated in compliance with FDA CSA guidance, 21 CFR Part 11, EU Annex 11, and internal Quality ... including 21 CFR Part 11, 21 CFR Part 820, EU Annex 11, and FDA software validation guidance. + Experience supporting or leading CAPA, deviation, nonconformance, and… more
- Actalent (Santa Clara, CA)
- …in full compliance with the company's Design Control requirements and consistent with FDA , ISO, and MDD standards. This role is focused on supporting new product ... for medical devices. + Ensure software meets company and industry standards including FDA , ISO, and MDD. + Participate in the entire product lifecycle from concept… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Kelly Services (Petaluma, CA)
- …scaling and managing the QA team + Ensure regulatory compliance with GMP, FDA , ISO13485 and combination product requirements + Assist in launch readiness and quality ... a pharmaceutical environment (combination product experience a plus). + Expertise in FDA regulations, ISO standards, drug/device compliance + BS/MS in a related… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
- Terumo Neuro (Aliso Viejo, CA)
- …+ Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room monitoring and validation activities, ... four (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring. 4. EN… more
- Abbott (Pleasanton, CA)
- …+ **Compliance & Security** : Ensure systems meet regulatory standards (eg, HIPAA, FDA CFR Part 11, ISO 13485). + **Observability** : Implement and optimize ... in regulated industries (medical devices, pharma, healthcare). + Knowledge of FDA software validation processes. + Experience with real-time monitoring and alerting… more
- Abbott (Pleasanton, CA)
- …and issues. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and ... and issues. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …& Risk Management** + Ensure all training programs meet global regulatory standards ( FDA , EMA, ICH, etc.) and internal SOPs. + Monitor training compliance metrics ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… more