- Grifols Shared Services North America, Inc (San Carlos, CA)
- … authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to ... including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams,...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project … more
- Hyundai Autoever America (Costa Mesa, CA)
- …schedules + Work with HAEA and other regulatory agencies for certification and compliance + Manage project risks and resolve issues + Regularly report ... Project Manager I, Connected Car System Issue and Quality Validation Management Purpose: We are seeking a PM...overall connected car systems + Communicate with internal R&D, quality , regulatory teams, and external partners +… more
- Envista Holdings Corporation (Brea, CA)
- …procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations. + Collaborate with global ... distributors, in-country consultants, inter-company partners, and commercial teams to fulfill regulatory requirements for product registration and compliance . +… more
- Medtronic (Santa Rosa, CA)
- …and influences the preparation of documentation to support innovative and high- quality regulatory submissions from early phase strategies, marketing ... work together to engineer the extraordinary. Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and their… more
- Deloitte (Sacramento, CA)
- …or operational evolutions + Direct working experience related to product management, regulatory compliance , risk management or controls oversight + Direct ... The Team Our Regulatory & Financial Risk offering supports clients' regulatory and compliance needs, balancing risk and regulatory requirements… more
- Sumitomo Pharma (Sacramento, CA)
- …staff contracted to publish and dispatch health authority submissions. + Represents Regulatory Operations on project teams for matters relating to electronic ... agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions. Guides and trains project teams on new requirements,… more
- Abbott (Santa Clara, CA)
- … requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory ... business units with their regulatory submissions. Collaborates closely with internal regulatory colleagues to ensure project strategies and regulatory … more
- Envista Holdings Corporation (Brea, CA)
- …by relevant authorities, assess their impact on the organization, and provide timely regulatory guidance and support to ensure compliance . + Develop and maintain ... review and evaluation of product, manufacturing, and labeling changes to determine regulatory reporting requirements and ensure ongoing compliance . + Follow… more
- Meta (Burlingame, CA)
- …regulatory agencies as needed 4. Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for ... All significant issues will be reviewed with the manager 2. Support regulatory compliance activities, including site registration, audits, post-market vigilance… more
- Edwards Lifesciences (Irvine, CA)
- …Edwards. Providing exceptional legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this role will also ... guidance and support to Edwards' leaders on medical device commercial, clinical, regulatory , quality and reimbursement related legal matters, including ongoing… more