- Medtronic (Los Angeles, CA)
- …+ Experience leading Field Corrective Actions / Recalls + Expert knowledge of global regulatory requirements (eg, FDA 21 CFR 806, EU MDR) for field ... Experience leading cross-functional teams + Strong experience working with FDA , EU, and other global regulatory bodies...working with FDA , EU, and other global regulatory bodies + Strong experience implementing or managing digital… more
- Parexel (Sacramento, CA)
- …when applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- US Tech Solutions (Thousand Oaks, CA)
- …conditioning and Packaging line engineering studies + Ensure compliance with global regulatory expectations ( FDA , EMA, ISO 11607, USP). + Prepare and ... review packaging documentation for regulatory submissions. + Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs. + Lead… more
- Medtronic (Northridge, CA)
- …+ Strong knowledge of contract negotiation, supplier performance management, and regulatory compliance ( FDA , ISO 13485). + Excellent communication, stakeholder ... amendments with key IT vendors, ensuring alignment with internal policies and regulatory standards. + Provide expert guidance on IT pricing models, standard market… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, ... EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses. + Expert in leading through ambiguity, can assess options quickly and… more
- Astrix Technology (Pomona, CA)
- …of food safety programs: HACCP, GMP, allergen control, environmental monitoring, and regulatory standards ( FDA , USDA, AIB). + Strong communication skills with ... QA activities on the afternoon shift, ensuring all products meet safety, regulatory , and customer standards. The ideal candidate is proactive, confident in… more
- Cytel (Sacramento, CA)
- …comfortable interfacing with **senior executives** . + Experience interacting with ** regulatory agencies ( FDA /EMA)** and **key opinion leaders (KOLs)** . ... collaborating with a team of consultants and analysts to define optimal ** regulatory , clinical, and/or market access pathways** . + Develop **innovative solutions**… more
- US Tech Solutions (San Bruno, CA)
- …Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory ... and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical devices from...Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products… more
- IBM (San Francisco, CA)
- …PLM platforms, ERP, and other business applications. . Ensure systems comply with regulatory standards ( FDA , GxP, ISO, OSHA) and internal governance policies. . ... Troubleshoot complex application issues and guide root-cause analysis and long-term remediation efforts. . Stay current with industry trends, new platform capabilities, and emerging digital technologies. This job can be performed from anywhere in the US.… more
- Astrix Technology (Anaheim, CA)
- …year in a leadership experience. + Strong knowledge of food safety programs and regulatory standards ( FDA , USDA, AIB, HACCP, GMP, Allergen Programs). + Excellent ... verbal and written communication skills in English. + Proficient in Microsoft Office Suite, including Word, Excel, and Outlook. \# INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard… more