- Amgen (Thousand Oaks, CA)
- …quality systems. + Ensure site's process validation business process adheres to global regulatory agency standards, Amgen's quality requirements, other site ... process technology transfer and other technical documents. **Process Validation & Regulatory Support** + Development of validation plans and supports execution of… more
- BeOne Medicines (Emeryville, CA)
- …ensure robust study design, insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK modeling, including ... . Ensure high-quality, compliant, and timely delivery of statistical components for regulatory submissions (eg, INDs, NDAs, BLAs, and global equivalents). .… more
- Cordis (Irvine, CA)
- …Team Leader, ability to inspire and support a team. + Proven track record in global regulatory body interactions + Strong communication skills. + Global , ... at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements. + Process Improvement: Lead the… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...database configuration updates, submission rules management and testing with regulatory authorities. + Serve as a subject matter expert… more
- Element Materials Technology (Morgan Hill, CA)
- …who canapply engineering problem solving skills to evaluate wireless devices for global Regulatory compliance involving EMC/RF Testing for wireless consumer ... technologies to determine FCC (US) and ISED (Canada), and other global regulatory body compliance. Salary: $38-45/hr **Responsibilities** + Performs… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …PSO provide guidance to successfully deliver best-in-class secure products, consistent with global regulatory requirements over the lifecycle. This role works in ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...partnership with R&D, Enterprise Security, Quality, Regulatory Affairs, and leaders at corporate, regional, and business-unit… more
- Sumitomo Pharma (Sacramento, CA)
- …of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product… more
- Western Digital (Sacramento, CA)
- …updates to senior leadership and key stakeholders. + Ensure compliance with global regulatory and sustainability standards throughout the supply chain lifecycle. ... **Company Description** At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of medical device, medical device accessory, and combination product global regulatory registration processes and requirements, international supply ... Description** We are **the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health (TM) is… more
- Danaher Corporation (Sunnyvale, CA)
- …Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... regulatory authorities + Provide cross-functional compliance support for global QMS and Intracompany Quality Agreement requirements. Function as SME for… more