- Eurofins US Network (San Jose, CA)
- …validate, and maintain EO sterilization processes in compliance with ISO 11135, FDA , EPA, and other applicable standards. + Support new product development through ... knowledge of EO sterilization regulations and standards, including ISO 11135, cGMP, FDA , and EPA NESHAP. + Experience with validation, quality assurance, document… more
- Actalent (Los Angeles, CA)
- …source documents to ensure that research is being conducted according to IRB, FDA , OHRP, HIPAA and other agency guidelines. * Maintains high quality, up-to-date ... regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies. * Completes appropriate IRB… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. + ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
- J&J Family of Companies (Santa Clara, CA)
- …to the Quality Assurance group + Support internal and third-party audits ( FDA , Notified Body) + Participate in Material Review Board (MRB) meetings _Manufacturing ... in the medical device industry is strongly preferred + Strong understanding of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems + Strong technical writing… more
- Abbott (Sylmar, CA)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements. + Professional certification or designation… more
- Cedars-Sinai (Beverly Hills, CA)
- …study budget and research participant billing. This role follows all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Cedars-Sinai (Los Angeles, CA)
- …study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Sutter Health (Sacramento, CA)
- …privacy, and clinical safety risks. -Ensure compliance with HIPAA, HITECH, CMS, FDA (for medical device security), and state privacy regulations. -Oversee security ... & Skills** + Deep knowledge of HIPAA, HITECH, CMS, OCR enforcement, FDA guidance for medical devices, and healthcare-specific risk management frameworks. + Expertise… more
- Edwards Lifesciences (Irvine, CA)
- …MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development ... process, GCP, ICH guidelines and Global (US FDA , EU MDR) regulations. + Experience working in a cross functional, collaborative environment and comfortable… more
- Edwards Lifesciences (Irvine, CA)
- …including proficiency with Microsoft Word + Familiarity with regulatory standards (ISO, FDA ) and design control processes. + Ability to work well independently and ... authoring deliverables for regulatory submissions to regulatory authorities including the FDA Aligning our overall business objectives with performance, we offer… more