- Abbott (Pleasanton, CA)
- …and US device regulations and/or experience with EU and other international medical device regulations and submissions. + Ability to work in a highly ... for US, EU (EU MDR), and other international geographies. + Experience with medical device software requirements and software regulations. + Ability to identify… more
- Abbott (Pleasanton, CA)
- …related field + Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Cardinal Health (Sacramento, CA)
- …regulation) preferred * Experience in private practice strongly preferred * Familiarly with medical device and pharmaceutical regulation * Active license in good ... **_What Regulatory contributes to Cardinal Health_** Legal provides the...regulations; and other product-specific environmental / sustainability drug and device lifecycle obligations and stewardship programs. This role will… more
- Abbott (Alameda, CA)
- … device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical ... Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a… more
- J&J Family of Companies (Santa Clara, CA)
- … fields is preferred + 0 - 1 years' experience in medical device , life science, pharma industry Experience in regulatory affairs is preferred + Highly ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving,… more
- Oura (San Francisco, CA)
- …quality system, including external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. + Experience with privacy ... tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a...related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices, digital… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination ... Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Regulatory Affairs Process Specialist for a 6-month contract opportunity with a leading molecular diagnostics company based ... in the biotechnology realm. **Workplace:** Remote US **Position Title:** Regulatory Affairs Process Specialist **Position Type:** 6-month contract **Pay rate:**… more
- Kelly Services (Irvine, CA)
- …* At least 5 years of experience in a Quality, Manufacturing or Engineering function in medical device industry * At least 5 years of experience in a Quality, ... ** REGULATORY COMPLIANCE - SENIOR ANALYST (Hybrid)** QUALIFICATIONS: a)...Manufacturing or Engineering function in medical device industry * Experience with MDSAP… more
- Abbott (Santa Clara, CA)
- …Multitasks, prioritizes and meets deadlines in a timely manner. + Experience working in the Medical Device industry. + Certification is a plus (such as RAC from ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more