- BD (Becton, Dickinson and Company) (Milpitas, CA)
- **Job Description Summary** We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is responsible for ... preparing and managing regulatory submissions to support the global commercialization of new...+ Familiarity with ISO 13485/900, EU IVDR and US FDA 510 requirements. + Experience with reviewing and approving… more
- The Clorox Company (Pleasanton, CA)
- …**Your role at Clorox:** The Senior Regulatory Specialist will serve as a strategic ... business, supporting product development, commercialization, brand maintenance, implementation of regulatory best practices, and maintaining a robust compliance program… more
- Parexel (Sacramento, CA)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... drug development-we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding… more
- Sumitomo Pharma (Sacramento, CA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research… more
- Lilly (San Diego, CA)
- …expertise to regulatory scientists. + Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more
- Edwards Lifesciences (Irvine, CA)
- …to work from home as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory Counsel and will be ... assistance with state licensing, support for sales contracting, and other legal regulatory duties as needed. The Manager provides legal guidance to Marketing and… more
- Edwards Lifesciences (Irvine, CA)
- …and analyze accurate date of regulatory reports for submission for the regulatory bodies (eg, FDA ) + Identify technical and data issues and collaborate ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Envista Holdings Corporation (Orange, CA)
- …improve product performance, reliability, and clinical outcomes, while maintaining compliance with FDA , ISO 13485, and other regulatory standards. Design & ... champion engineering excellence, and collaborate cross-functionally to deliver high-performance, regulatory -compliant solutions that elevate clinical outcomes. If you're passionate… more
- Terumo Neuro (Aliso Viejo, CA)
- …and required quantity for validation. + Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO. + Support clean room ... four (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring. 4. EN… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …reports and presentations. Conduct verification and validation testing in accordance with FDA and ISO standards. Support regulatory submissions by documenting ... delivery systems, mechanical ventilators and anesthesia delivery systems. Experience with FDA design controls and IEC software lifecycle processes. Knowledge of… more