- Stryker (Irvine, CA)
- …process-related issues. + Document processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 25539 (vascular implants). ... (Minitab, JMP). + Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II/III interventional devices. + Hands-on experience with… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... all other applicable laws, regulations, and standards. **Qualifications** Experience: + Minimum five (5) years previous service-related experience. + Demonstrated ability at operating installation tools and test equipment. + Extensive knowledge and experience… more
- Abbott (San Diego, CA)
- …Abbott Chronic Pain Therapies product line. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company ... policies, operating procedures, processes, and task assignments. + Provides sales support, clinical in-services, training, and guidance to current or potential customers. + Maintains positive and cooperative communications and collaboration with all levels of… more
- BeOne Medicines (San Mateo, CA)
- …(zanubrutinib), TEVIMBRA(R) (tislelizumab), and future products in our pipeline pending FDA approval. This individual will develop our digital strategy and apply ... Medical and Value Organization (MVO), Medical Affairs, Brand Marketing, Legal & Regulatory , and our Global Operations & Business Analytics teams is paramount.… more
- Fresenius Medical Center (Apple Valley, CA)
- …Health & Safety, DOT, and Compliance. + Remains up-to-date with all annually revised regulatory standards (OSHA, DOT, EPA, FDA , and state specific agencies). + ... Orientation/Gender Identity Fresenius Medical Care North America maintains a drug -free workplace in accordance with applicable federal and state laws.… more
- GRAIL (Menlo Park, CA)
- …oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations ... knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture system, CTMS… more
- Cedars-Sinai (Los Angeles, CA)
- …compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Key Responsibilities:** ... Excellent written and verbal communication skills. + Ability to strictly adhere to regulatory requirements and ethical guidelines. This role is designed to be 100%… more
- Stryker (San Jose, CA)
- …to provide design and process inputs for serviceability whilst adhering to regulatory requirements, project deadlines and product costs. + Analyze, determine, and ... of applicable domestic and international regulations and quality system standards - FDA QSR, MDD, ISO13485, ISO9001, etc. + Experience in independently executing… more
- University of Southern California (Los Angeles, CA)
- …spans the entire spectrum of pharmaceutical development and clinical care - from drug discovery to regulatory approaches that promote safety and innovation, from ... and we have become a trusted resource for Congress, federal agencies (including CMS, FDA , CBO, and NIH), and organizations such as the National Academies of Science,… more
- Compass Group, North America (San Francisco, CA)
- …wellness related programs and initiatives and to ensure compliance with FDA nutrition labeling laws. **Key Responsibilities:** + Understands and executes Bon ... op-in wellness offerings. + Supports account in meeting nutrition related regulatory requirements including federal menu labeling laws, local and state requirements… more