- US Tech Solutions (San Bruno, CA)
- …in software development for medical devices , specifically focusing on Software as a Medical Device ( SaMD ) or low-risk enforcement discretion ... CAPA, complaints, audits, and overall QMS functions. **Mandatory:** + Medical Device Software Experience: +...strictly on software quality engineering in a software -only context. **Skills:** + QMS + SaMD … more
- Meta (Burlingame, CA)
- …have deep domain experience in electromechanical devices and software as a medical device ( SaMD ). **Required Skills:** Head of Medical Devices ... regulators in particular for Software as a Medical Device ( SaMD ) products 11....of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD… more
- US Tech Solutions (San Bruno, CA)
- …+ Experience in Medical Device Manufacturing or Software as a Medical Device ( SaMD ). + Experience with Quality Management Systems (QMS). + 3+ ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more
- Abbott (Pleasanton, CA)
- …Prior experience in a software -focused company or company with software as a medical device ( SAMD ). The base pay for this position is $144,100.00 - ... of FDA regulations and guidance, ISO 13485, Software Standards (eg, IEC 62304), EU Medical Device Regulations, and MDSAP **Preferred Qualifications**… more
- Abbott (Alameda, CA)
- …and corrective and preventative action of medical devices , including software as a medica device ( SaMD ), in-vitro, diagnostic devices ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....and Marketing to support mobile app deployment activities (for Software as a Medical Device … more