- Abbott (Alameda, CA)
- …focused manufacturing environment. * Working knowledge of regulations and standards affecting Medical Device manufacturing (eg QSR, ISO, EN Quality System ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more
- Abbott (Alameda, CA)
- …for the Medical Events Group as required. + Accountable for meeting the compliance requirements for Medical Device Reporting (803), including but not ... and scientists. The Opportunity Responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem… more
- Abbott (Alameda, CA)
- … Events Team provides direct supervision and management to staff responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports ... healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000... Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest… more
- Abbott (Alameda, CA)
- …the rest of world for the division's products. Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). ... and scientists. **The Opportunity** Responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem… more
- Abbott (Alameda, CA)
- …technical, manufacturing, quality, or supply chain experience in a health care/ medical device company + Excellent interpersonal skills and demonstrated ... healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000...experience + Minimum 5 years working in a regulated medical (ideally device or in vitro Diagnostic)… more
- Abbott (Alameda, CA)
- …years Quality Assurance, Technical Quality, or equivalent + Minimum 3 years medical device manufacturing industry **Preferred Qualifications** + Some Knowledge ... healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000...QSR and ISO regulations + Knowledge and experience with medical device regulations for device … more
- Abbott (Alameda, CA)
- …of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve ... Abbott is a global healthcare leader that helps people live more fully...assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar… more
- Abbott (Alameda, CA)
- …of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve ... Abbott is a global healthcare leader that helps people live more fully...of new product development, product testing, process improvement and compliance with regulatory requirements. + May lead technical teams… more
- Abbott (Alameda, CA)
- …V&V test protocols. + Ensure that electrical designs meet applicable industry and medical device standards + Communicate effectively to and participate in ... as DOORS and SysML a plus + Knowledge of regulations and industry standards for medical device development including but not limited to ISO 13485, ISO 14971, and… more
- Abbott (Alameda, CA)
- …of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve ... Abbott is a global healthcare leader that helps people live more fully...assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar… more
- Abbott (Alameda, CA)
- …US biologics regulations, US drug regulations or with EU and other international medical device regulations and submissions. + Familiar with relevant regulatory ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more
- Abbott (Alameda, CA)
- …discipline. + 8+ years' experience in a Software Quality Assurance experience in a medical device company + 3+ years' experience leading a team of technical ... and 21 CFR Part 11. **Preferred Qualifications** + Prior experience in a medical device company with mobile application software (iOS, Android) highly preferred… more
- Abbott (Alameda, CA)
- …Expertise in a **regulated industry** **Preferred Qualifications** + Experience in the medical device industry. + Proficiency in data analysis and project ... visual decision trees, and document management life cycles. + Knowledge of medical device reporting, regulatory audits, and inspections. + Six Sigma… more
- Abbott (Alameda, CA)
- …monitoring, clinical trial practices and regulations. + Experience in conducting medical device and/or _in-vitro_ diagnostics studies. Pharmaceutical background ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more
- Abbott (Alameda, CA)
- …Engineering or Biomedical Engineering + Strong understanding of regulatory requirements in the medical device space + Experience with project management and ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more
- Abbott (Alameda, CA)
- …Windchill, Oracle Agile, Veeva Vault etc. **Preferred Qualifications** + Experience in the medical device industry. + Working knowledge of data analytics and ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more
- Abbott (Alameda, CA)
- …+ Prior experience in a software-focused company or company with software as a medical device (SAMD). + Prior experience in EQMS launches and/or QMS Transitions. ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more
- Abbott (Alameda, CA)
- …experience in the Quality or Compliance and Technical discipline, in the Medical Device Industry or other FDA regulated industry. + Demonstrated progression ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more
- Abbott (Alameda, CA)
- …of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve ... Abbott is a global healthcare leader that helps people live more fully...We're always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott,… more
- Abbott (Alameda, CA)
- …+ Stay updated with industry trends and best practices, especially in the medical device sector. **Required Qualifications** + Bachelor's degree in computer ... of healthcare , with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve… more