- Abbott (Pleasanton, CA)
- …project teams** to drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA, ISO 13485). + ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Santa Clara, CA)
- …providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... on regulatory activities and works with the medical device business units that Leverage Services...experience in regulatory affairs; highly preferred with medical devices . + At least 5 years… more
- Philips (San Diego, CA)
- **Senior/Staff Digital Electrical Engineer** **- FPGA for Medical Devices (San Diego, CA)** As a member of an international cross-functional team, you work ... of formal verification and validation plans in collaboration with Quality and Regulatory teams, actively participating in...a related field. Experience applying IEC 60601-1 and related medical device electronics standards is desirable. +… more
- Caldera Medical (Westlake Village, CA)
- …your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... regulatory input and guidance to cross-functional partners regulatory documentation for medical device ...Medical is a growth stage medical device company dedicated to improving the quality … more
- Oura (San Francisco, CA)
- … affairs, or a related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices , digital health, or wearable ... of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play...external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. +… more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with… more
- Kelly Services (Irvine, CA)
- …_Ability to communicate effectively, both in writing and verball_ + _Familiarity with quality and regulatory systems including FDA's Quality System ... _for a long-term contract at one of our_ **_Global Medical Device_** _clients, located in_ **_Irvine, CA_** _._ _Our...with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide_ _As a… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices , and/or… more
- Abbott (Santa Clara, CA)
- …in a broader enterprise/cross-division business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....plus. . Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international… more