- Abbott (Sylmar, CA)
- … compliance , legal, contracts & pricing, procurement, legal operations, regulatory affairs, governmental affairs, audit, and/or finance. + Experience with ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Danaher Corporation (San Diego, CA)
- … programs and teams in metric/KPI-driven global manufacturing organizations in medical device manufacturing or other highly-regulated sectors. + Deep ... and identify process improvement opportunities. + Develop and implement comprehensive compliance training programs that ensure regulatory awareness and expertise… more
- Amazon (Sunnyvale, CA)
- …in this role involves working with cross-functional and outside partners on regulatory compliance initiatives, connecting with our product development team to ... establish testing protocols, manage certification processes, and interface with regulatory bodies. Beyond compliance , the engineer proactively shapes… more
- Caldera Medical (Westlake Village, CA)
- …* Ensure timely and accurate complaint evaluations, including medical device reporting (MDR) or equivalent regulatory submissions. * Collaborate with ... complaints and working on CAPA. * Bachelor's degree preferred. * Experience working within medical device industry and familiarity with 21 CFR 820, and ISO 13485… 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 ... designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design,...ISO and + ASTM standards related to quality and medical device industry. + Independently assesses if… more
- Abbott (Alameda, CA)
- … History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Develops ... the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This...5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO… more
- US Tech Solutions (San Bruno, CA)
- …software development lifecycle, ensuring adherence to high standards and corporate requirements. ** Regulatory Compliance :** 1. Ensure compliance with US FDA ... Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1. Support the creation… more
- J&J Family of Companies (Irvine, CA)
- …Quality & Compliance , Health Economics & Market Access, and Professional Medical Education to influence overall regulatory and commercial strategy, as well ... report for all new products + Account for the medical content of internal product documentation and regulatory...Medical /Clinical/R&D teams in a regulated, commercial biomedical or medical device business is strongly preferred 9.)… more
- Stryker (San Jose, CA)
- … Medical Device (SaMD) and Software in a Medical Device (SiMD), supporting post-market activities to ensure compliance , drive customer quality, and ... Action and Preventative Action (NC/CAPA). Additionally, extensive experience within themedical device industry, ensuring compliance with regulatory standards… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non- Medical device products and software + ... + Lead and develop direct report associates to ensure regulatory compliance + Problem solve and escalate...to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the… more