- Deloitte (San Jose, CA)
- …capabilities to build, deploy, and operate integrated/verticalized sector solutions in software , data, AI, network, and hybrid cloud infrastructure. These solutions ... familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND,… more
- Fujifilm (Sacramento, CA)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Danaher Corporation (Brea, CA)
- …in: + Experience with healthcare regulation, including: fraud and abuse (eg, anti-kickback); FDA for medical devices; data use and privacy (eg, HIPAA, GDPR); and ... anti-corruption (eg, FCPA) + Experience with software transactions The salary range for this role is $160,000-$190,000 annually. This is the range that we in good… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …(MMS) dispensing products, including non-medical devices, medical devices, associated software , and accessories on a global scale. **Responsibilities** + Support ... with new and existing US and international regulations and directives (eg, FDA Medical Device Regulations, EU Low Voltage Directive, EU Electromagnetic Compatibility… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …vendor resources + Identify/create new product features and collaborate with Software development team through clear communication, wireframes, and storyboards + ... of regulatory requirements and quality standards in the medical device industry ( FDA , ISO 13485, ISO 60601) + Excellent problem-solving skills and ability to… more
- Imperative Care (Campbell, CA)
- …and other areas of testing and analysis should translate into hardware and software implementations of repeatable test methods. + Develop test methods and equipment ... new solutions, and incorporate continuous improvements stemming from technology advancement, FDA feedback, and/or applicable standards What You'll Bring + Bachelor's… more
- Danaher Corporation (Brea, CA)
- …in: + Experience with healthcare regulation, including: fraud and abuse (eg, anti-kickback); FDA for medical devices; data use and privacy (eg, HIPAA, GDPR); and ... anti-corruption (eg, FCPA) + Experience with software transactions The salary range for this role is $160,000-$190,000 annually. This is the range that we in good… more
- Fujifilm (Sacramento, CA)
- …+ Provide on-going customer support for HCUS MRI products, including: + Software updates. + System upgrades. + Performance troubleshooting follow-up visits. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Science in an engineering field (Mechanical, Systems, Physics, Electrical, Biomedical, Software ) + 10+ years of progressive responsibility in R&D technical ... pre-market and post-market development activities + Experience in regulated industries ( FDA , Automotive, Industrial, etc.) At BD, we prioritize on-site collaboration… more
- ZOLL Medical Corporation (San Jose, CA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more