- Danaher Corporation (West Sacramento, CA)
- …Microbiology Team via PPG, and functional leaders. + Drive achievement of Quality , Cost, and Delivery (QCD) metrics. + Identify risks and implement countermeasures ... pay. We offer comprehensive package of benefits including paid time off, medical /dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay… 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)
- … system, including external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. + Experience with privacy and ... of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play...related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices, digital… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with… 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...have targeted mitigations to align with FDA expectations, ensuring high- quality submissions and predictability for approval + Assists BU… 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 ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- GRAIL (Menlo Park, CA)
- …, development, clinical affairs, quality , or program management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and ... knowledge of US and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator in dynamic,… 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 ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...including evaluation of cybersecurity risks. + Collaborate with R&D, Quality , Marketing, and Regulatory teams to ensure… 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 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