- Cordis (Irvine, CA)
- …products. This role is responsible for ensuring compliance with global regulatory requirements for combination products, including device and drug cGMPs, and ... risk management. The role partners closely with Quality, Manufacturing, R&D, Regulatory , and external contract manufacturers to ensure product safety, quality, and… more
- Penske (La Mirada, CA)
- …and implementing compliance strategies, conducting facility inspections, managing regulatory relationships, and producing detailed annual compliance reports to ... regulations * Establish protocols for timely inspections, equipment maintenance, and regulatory compliance * Design and oversee employee training programs for… more
- Amgen (Thousand Oaks, CA)
- …leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory , Process Development, Quality Assurance, and other functional areas ... methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for… more
- Mitsubishi Chemical Group (Irvine, CA)
- …Fiber and Composites businesses (MCCFC). Perform technical activities leading to product regulatory compliance, assessment of product safety to human health and the ... for these assessments. Maintain and expand in-depth knowledge of global regulatory requirements and develop business processes to ensure assessment and compliance… more
- Oracle (Sacramento, CA)
- …visible leadership position, you will drive programs that integrate SaMD regulatory requirements into engineering workflows, SDLC practices, release processes, and ... delivery models. You will partner closely with Engineering, Product, Quality, Regulatory , Clinical, Security, and Compliance teams to ensure Oracle's healthcare… more
- Oracle (Sacramento, CA)
- …Oracle Health Data Intelligence (HDI) is entering a critical phase of regulatory and security modernization across our global health analytics and AI-enabled ... platform. As HDI accelerates readiness for MDR (Medical Device Regulation), AI regulatory requirements, and emerging global security standards, we are expanding our… more
- Oracle (Sacramento, CA)
- **Job Description** Oracle Health is transforming its development and regulatory processes to meet heightened FDA, MDR, and ISO 14155 standards and address ongoing ... role is essential in modernizing our clinical risk management and regulatory practices in partnership with AI-driven process improvements. **Qualifications** .… more
- Parexel (Sacramento, CA)
- …while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient ... safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance… more
- J&J Family of Companies (Irvine, CA)
- …medical and/or technical expert in communications with FDA and other Regulatory agencies worldwide. Oversees post market clinical activities for product portfolio. ... and implement clinical research strategies that align with product development and regulatory requirements. + Lead and mentor a team of clinical scientists and… more
- Oracle (Sacramento, CA)
- …for regulated medical devices. This role bridges product development, regulatory , and enterprise architecture functions-ensuring that device software solutions are ... designed securely, maintain regulatory compliance, and align with enterprise standards and long-term...aligned with device-level safety, performance, and compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to… more