- Terumo Neuro (Aliso Viejo, CA)
- …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and...to coach and mentor. 4. Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices.… more
- Stanford Health Care (Palo Alto, CA)
- …Ensures organizational compliance with federal/state regulations and accreditation requirements ( FDA , CDPH, BOP, TJC, etc.) for medication management. Develops audit ... managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, sample medications, investigational studies,… more
- Kelly Services (Valencia, CA)
- …for a leading client. In this role, you'll ensure compliance with FDA , ISO, and international regulations and submissions while managing regulatory programs across ... two facilities. **Key Responsibilities:** + Oversee regulatory submissions ( FDA , EU MDR, international). + Maintain product registrations, certifications, and export… more
- Stryker (San Jose, CA)
- …teams and authorities. + Participate in internal and external audits ( FDA , notified bodies), addressing sterilization and biocompatibility topics. + Apply ISO, ... FDA , and other relevant standards to biological and microbiological...techniques and industry standards. + Experience applying ISO and FDA guidelines to product development and manufacturing. + Ability… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure Quality incidents ... with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations...in training Managers, supervisors and personnel on Company and FDA GMP procedures + Audit/Assess assigned LG&E manufacturing and… more
- Fujifilm (Sacramento, CA)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- Astrix Technology (Gardena, CA)
- …completion, accuracy, and compliance with established protocols. + Support compliance with FDA , SQF, and other regulatory body requirements. + Ensure accuracy of ... + Minimum 2 years of experience in QA Documentation. + Proficiency with ** FDA , USDA, AIB, HACCP, GMP, and Allergen Programs.** + Understanding of labeling… more
- Abbott (Temecula, CA)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and vendors. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and… more
- Abbott (Milpitas, CA)
- …the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and ... biowearable products, ensuring on-time delivery within budget. + Implement FDA -compliant design control procedures. + Provide technical leadership and mentoring… more
- Hologic (San Diego, CA)
- …product complaints in compliance with Hologic SOPs and applicable regulatory requirements ( FDA , ISO, EU MDR). + Conduct initial assessments and work with ... Regulatory Reporting + Support preparation and submission of regulatory reports (eg, FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements. +… more