- Children's Hospital Los Angeles (Los Angeles, CA)
- …product logistics, monitoring patient safety and adverse events, and ensuring compliance with FDA and institutional protocols. The Clinical Research ... regulatory documentation for BMT trials, including IND submissions and FDA correspondence. **Education/Licensure/Certification:** Bachelor's degree or Associate degree in… more
- Oura (San Francisco, CA)
- …product development, approval, and lifecycle management for all regulated features. + Ensure compliance with FDA , CE (MDR), and other relevant global regulatory ... consumer-facing wearables strongly preferred. + Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals. + Proven… more
- Astrix Technology (Irvine, CA)
- …Collaborate with cross-functional teams to drive product and process improvements + Maintain compliance with FDA , ISO 13485, and global quality standards + ... and documentation skills + Proficient in Microsoft Excel **Preferred:** + Knowledge of FDA regulations (21 CFR 820/803), ISO 13485 + Experience with medical device… more
- Actalent (Santa Clara, CA)
- …Generate evidence to qualify designs according to established standards. + Ensure compliance with FDA regulations through proper documentation. + Operate within ... of Quality Management Systems (QMS) and ISO standards. + Familiarity with FDA documentation requirements. + Experience with JAMA, JIRA, and IEC standards. Additional… more
- AbbVie (Pleasanton, CA)
- …& interpreting mechanical drawings & GD&T + performing daily assigned tasks in compliance with FDA 's Quality System Regulation (QSR), ISO 13485, ISO 14971, ... discipline. Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1… more
- Fortive Corporation (Irvine, CA)
- …Lead **IQ, OQ, PQ validation** for facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP, OSHA, and safety regulations** . + ... in a **GMP-regulated manufacturing environment** . This role ensures ** compliance , efficiency, and strategic growth** , overseeing **facility maintenance,… more
- Lilly (San Diego, CA)
- …as well as regulatory strategy development + Monitor patient safety and ensure compliance with GCP, FDA , ICH guidelines, and company policies **Cross-Functional ... Medical Affairs Support** + Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning + Contribute medical expertise to… more
- Alameda Health System (Oakland, CA)
- …protocols and screening requirements. Reports serious adverse events to study sponsor and FDA , when appropriate. Ensures compliance with all federal and state ... In collaboration with nursing staff, assures that operations are in compliance with external guidelines, statutory and accreditation parameters including JCAHO,… more
- Medtronic (Northridge, CA)
- …expertise in PLCs, MES (Factoryorx), and web services + Familiarity with FDA -regulated manufacturing or similar compliance environments. + Experience managing ... integrations + Reporting and analytics solutions for manufacturing + Ensure compliance with quality, regulatory (GxP), and security requirements. + Manage system… more
- Caldera Medical (Westlake Village, CA)
- …while also managing Corrective and Preventive Action (CAPA) activities to ensure compliance with FDA , ISO, and other applicable regulatory requirements. The ... Support audits and inspections by providing complaint records and demonstrating process compliance . CAPA Management * Lead and coordinate the CAPA process, ensuring… more