- Abbott (Alameda, CA)
- …and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. ... support mobile app deployment activities (for Software as a Medical Device projects). + Drives alignment during...Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. +… more
- Veterans Affairs, Veterans Health Administration (Long Beach, CA)
- …Report: Not required Preferred Experience: Specialized expertise in areas such as Medical Device Isolation Architecture (MDIA) and Specialized Device ... basis with limited oversight by senior biomedical engineers. They participate in medical device hazard investigations, to assure compliance with patient safety… more
- Medtronic (Irvine, CA)
- …+ Maintain up-to-date knowledge of cybersecurity regulations and standards specific to the medical device industry (FDA, HIPAA, IEC 62443, NIST, NIS 2, etc.). ... GRC (Governance, Risk, & Compliance), or external/internal audit, preferably within the medical device or healthcare industry. + Strong understanding of… 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. ... Sr Director, Medical Safety Officer San Diego, CA, United States...customers, and regulators. + Leadership skills to guide audits, regulatory interactions, and field action processes. + Analytical and… more
- Kelly Services (Irvine, CA)
- …Johnson & Johnson is rapidly expanding and is immediately hiring qualified R&D Medical Device Technician to support production demand and new product ... development. **Position Summary:** As an R&D Medical Device Technician you will play a...processes/product tests and audits for conformity to quality and/or regulatory requirements. + Performs self-inspections of own work. +… more
- Bausch + Lomb (Sacramento, CA)
- …departments (eg, R&D/Project Management, Clinical/ Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device ... areas to provide input on study-related documents and issues (DMP, SAP, drug/ device supplies, CSR, etc.). + Provides clinical operations input in the identification,… more
- Terumo Neuro (Aliso Viejo, CA)
- …**Title:** Scientist II, Product Development **Job Description:** Support the development of medical device products through R&D device design control ... synthesis, laboratory equipment and analytical techniques. 4. Intermediate knowledge of medical device technical development. 5. Intermediate knowledge of… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …knowledge of medical terms and human anatomy + Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations + Good ... and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports… more
- Edwards Lifesciences (Irvine, CA)
- …journey. **_Note: this Clinical Specialist will support field cases for PASCAL (mitral device ) in the local and surrounding region. Candidate based in the San Diego, ... ideal._** **How you will make an impact:** + Educate physicians on device handling, implantation and troubleshooting techniques related to the equipment required for… more
- Edwards Lifesciences (Los Angeles, CA)
- …journey. **_Note: this Clinical Specialist will support field cases for EVOQUE (tricuspid device ) in the local region, along coverage when needed in the broader US. ... ideal._** **How you will make an impact:** + Educate physicians on device handling, implantation and troubleshooting techniques related to the equipment required for… more