- Danaher Corporation (Sunnyvale, CA)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance . This position is part of the Quality ... compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …aspects-from concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance . This new role is ideal for someone who ... to commercialization-with a sharp focus on scientific rigor and regulatory compliance . This new role is ideal...conferences and scientific meetings. + Represent BDB externally with regulatory agencies, notified bodies, FDA , etc. +… more
- Biomat USA, Inc. (Van Nuys, CA)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- Biomat USA, Inc. (Bakersfield, CA)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- BeOne Medicines (San Mateo, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… more
- Envista Holdings Corporation (Pomona, CA)
- …develop, implement, and maintain quality assurance protocols that comply with regulatory requirements and industry standards. The Sr. Quality Engineer will possess ... a deep understanding of quality management systems, regulatory requirements, and risk management principles. The Sr. Quality Engineer will report directly to the… more
- Stanford University (Stanford, CA)
- …study specific milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance . Regularly inspect study document to ensure ongoing ... regulatory compliance . + Work with principal investigator to ensure Investigational...regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- Abbott (Alameda, CA)
- …the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual ... File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management...+ Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines,… more
- Cordis (Irvine, CA)
- …risk mitigation to ensure the safety and efficacy of medical devices. + Regulatory Compliance : Stay up-to-date with regulatory requirements, standards, and ... measures at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality...potential for this position to assume the quality program manager on MDR. + Supplier Collaboration: Work closely with… more
- Medtronic (Irvine, CA)
- …requirements for business continuity, operations security, cryptography, forensics, regulatory compliance , internal counter-espionage (insider threat detection ... the team, you will provide expertise in risk management, compliance , and security strategy, while also playing a key...regulations and standards specific to the medical device industry ( FDA , HIPAA, IEC 62443, NIST, NIS 2, etc.). +… more