- Abbott (Alameda, CA)
- … History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Collects, ... of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer...on new and on-market product design projects to ensure compliance with the internal design control process and external… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Hologic (San Diego, CA)
- …practices, particularly in Breast/GYN or General Surgery. + Strong knowledge of medical device regulations, compliance standards, and risk management ... Sr Director, Medical Safety Officer San Diego, CA, United States...dynamic and fast-paced environment. + Ethical and professional, ensuring compliance with regulatory and legal standards. +… 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
- Medtronic (Los Angeles, CA)
- …our technology transforms lives Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or ... to meet goals and objectives. Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance...to work effectively with in-house functional team + Strong Regulatory Compliance experience - understanding, interpreting and… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …* Minimum 15 years of progressive experience in Design Quality Assurance within the medical device industry. * At least 6 years of direct management experience. ... that all IPD products are designed and manufactured in compliance with applicable industry and regulatory standards...and technical QA staff. * Deep knowledge of global medical device regulations (FDA, EU MDR, etc.).… more
- Bausch + Lomb (Sacramento, CA)
- …departments (eg, R&D/Project Management, Clinical/ Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device ... clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance , and clinical data management. + Minimum 10-12… more
- Cordis (Irvine, CA)
- …and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices. + Regulatory Compliance : Stay up to date with ... regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these… more
- Gilead Sciences, Inc. (Foster City, CA)
- …The ideal candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA), and life sciences Quality Management and ... affairs, to design SAP BRH solutions that optimize batch release processes. ** Regulatory Compliance :** + Ensure that all SAP BRH solutions comply with… more
- Abbott (Milpitas, CA)
- …and validation testing. + Extensive knowledge of entire medical device development process from needs definition through regulatory approvals, production, ... engineering field. + 10-15 years of management and technical management experience in the medical device industry with minimum 5 years at a senior management… more
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