- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... functions of this job: This position typically works in usual medical , clinical working environments, including sites under construction. **The position may… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... + Ability to work effectively with customers in the medical field. + Ability to prioritize and handle multiple...a discipline is a plus. + Exposure to the medical field, particularly cardiology, is a plus. + Some… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... effective leadership and partnership with all members of the HCUS Medical Informatics organization and work effectively with other cross-functional departments in… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... + $49,500 variable comp opportunity + Company Car + Medical , Dental, Vision + Life Insurance + 401k +...against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... (Hospital Information System), RIS (Radiology Information System), and EMR(Electronic Medical Record). + Excellent verbal and written communication and presentation… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to support the needs associated with training others on the operation of medical imaging equipment and conveying to the Fujifilm organization the status of the… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …products to determine compliance with FDA's guidance on device versus non- device functionality. + Prepare, submit, and manage regulatory submissions for SaMD ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...of possible** BD is one of the largest global medical technology companies in the world. Advancing the world… more
- Abbott (Alameda, CA)
- …medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro… more
- Oura (San Francisco, CA)
- …digital health products, including wearable devices and related software, including Software as a Medical Device (SaMD), Software in a Medical Device ... and Good Manufacturing Practices (GMPs), as well as post-market compliance, including Medical Device Reporting (MDR), product recalls, corrective actions, and… more