- Bausch + Lomb (Sacramento, CA)
- …Management, Clinical/ Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and Clinical ... provide input on study-related documents and issues (DMP, SAP, drug/ device supplies, CSR, etc.). + Provides clinical operations input...ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BRH solutions, particularly in regulated environments such as pharmaceutical, biotech, or medical device manufacturing. + Experience with SAP S/4HANA and ... Release Process Optimization:** + Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to design SAP BRH… more
- Abbott (Pleasanton, CA)
- …& Quality Assurance: Ensure all test strategies and practices align with medical device regulatory standards (FDA, ISO, IEC 62304).Support documentation, ... to define and implement comprehensive test automation strategies for Abbott's next-generation medical device software portfolio (Class II and Class III devices).… more
- Hologic (San Diego, CA)
- …practices, particularly in Breast/GYN or General Surgery. + Strong knowledge of medical device regulations, compliance standards, and risk management processes. ... Safety Officer San Diego, CA, United States Hologic's Quality team is seeking a Medical Safety...customers, and regulators. + Leadership skills to guide audits, regulatory interactions, and field action processes. + Analytical and… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …development from concept to market + Strong knowledge of regulatory requirements and quality standards in the medical device industry (FDA, ISO 13485, ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...are committed to improving patient outcomes and enhancing the quality of life through our advanced hemodynamic monitoring solutions.… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... Science or other relevant engineering/technical degree and 10 years' experience in the medical device industry or a Master's Degree and 8 years' experience… more
- Dignity Health (Sacramento, CA)
- **Responsibilities** + Ensures a high quality medical staff by thoroughly investigating and verifying the credentials of all applicants to the medical staff ... staff/Allied Health categories + Provides a vehicle to improve quality via the medical staff committee process...monitoring and planning for budgets and expenses + Promotes medical staff compliance with regulatory and accreditation… more
- Actalent (San Diego, CA)
- …receipt, and implementation of new and revised labeling. Required Skills: + Experience in medical device labeling and regulatory compliance + Proficiency in ... labeling process for both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires cross-functional collaboration to… more
- Abbott (Milpitas, CA)
- …in model based design (UML or SysML), is highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Philips (San Diego, CA)
- …Biomedical Engineering, or a related field. Experience applying IEC 60601-1 and related medical device electronics standards is desirable. + You must be able ... **Senior/Staff Digital Electrical Engineer** **- FPGA for Medical Devices (San Diego, CA)** As a member...of formal verification and validation plans in collaboration with Quality and Regulatory teams, actively participating in… more