- Terumo Neuro (Aliso Viejo, CA)
- …Supports preparation and hosting activities for third party audits including FDA , Notified Body, corporate and international regulatory authorities' audits. Supports ... multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices. 4. Demonstrates… more
- Abbott (Sylmar, CA)
- …and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing ... regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Grifols Shared Services North America, Inc (Bakersfield, CA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends… 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
- Abbott (Pleasanton, CA)
- …new and modified products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational ... requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, company policies, operating… more
- Abbott (Los Angeles, CA)
- …developments * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, processes, ... and task assignments * Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors * Performs other related duties and responsibilities, on occasion, as assigned **EDUCATION AND… more
- Genentech (San Diego, CA)
- …combination of education and experience may be considered). + Knowledge of cGMP of FDA , ICH and EU regulations. + Controlled document review and /or batch release ... experience preferred. + Basic understanding of Deviations, CAPAs and Change Control processes. + Basic computer skills in Excel, PowerPoint, and word processing. + Detail oriented with strong written and verbal communication skills. Ability to work… more
- Actalent (Irvine, CA)
- …+ Expertise in non-conformances, investigations, and CAPA processes. + Knowledge of FDA regulations and risk mitigation strategies. + Strong technical writing skills ... and documentation experience. Additional Qualifications + Bachelor's degree with 2+ years of relevant experience. + Proficiency in NCMR, product discrepancies, and change control systems. Work Environment This is an on-site role in a manufacturing setting… more
- Abbott (Alameda, CA)
- …with requirements and regulations may lead to nonconformances resulting in FDA sanctions. + Responsible for compliance with applicable Corporate and Divisional ... Policies and performing other duties as assigned by management **Required Qualifications** + 1-2 years of college or high school diploma with relevant experience. + Good organizational, written, oral and interpersonal skills. + Good Computer Skills. Basic… more
- J&J Family of Companies (Santa Clara, CA)
- …regulations and standards for medical devices and robotic surgery platforms, including FDA regulations and guidance, and IEC and ISO standards is preferred. + ... Demonstrated success building high-performing, customer-facing technical/clinical teams and establishing scalable processes across multi-program environments is preferred. + Have the ability to travel up to 15% of the time is required. **Perks** + Generous… more