- Abbott (Sylmar, CA)
- …of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements + Aligns with US Food and Drug Administration ( FDA ... ) regulations, Company policies, operating procedures, processes, and task assignments **Required Qualifications** + Environmental work experience, Bachelor's Degree in environmental studies, health sciences, or an equivalent academic field + Experience… more
- Cordis (Irvine, CA)
- …information request about off-label products or indications + Collaborate with regulatory and compliance teams to ensure all scientific/marketing materials adhere to ... relevant regulations and standards (eg, FDA , CA, PMDA,Sunshine Act) + Responsible for identifying clinical insights and knowledge gaps and be able to articulate the… more
- Abbott (Sylmar, CA)
- …Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. + Performs other related duties and responsibilities, on ... experience and demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971. + Solid communication and interpersonal… more
- ManpowerGroup (San Diego, CA)
- …V&V and QA. + Ensure compliance with internal standards and regulatory requirements. **Qualifications:** + Bachelor's degree in Computer Science, Engineering, or ... **Preferred:** + Experience with medical device regulations (ISO 13485, IEC 62304, FDA 21 CFR Part 820). + Familiarity with cloud testing and post-market… more
- Edwards Lifesciences (San Diego, CA)
- …and respond to ad hoc requests from internal stakeholders. + Maintain Regulatory Compliance: Stay current with training and ensure all activities align with ... ACCME, OIG, and FDA guidelines, as well as Global Compliance policies. + Contribute to Continuous Improvement: Participate in process enhancements and support the… more
- Abbott (Pleasanton, CA)
- …Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption ... Legal, Compliance, Finance, Education, Supply Chain, Research & Development, Regulatory , Quality, Clinical, Marketing, Commercial/Sales, and Information Technology Departments.… more
- ThermoFisher Scientific (Fremont, CA)
- …potentially hazardous chemicals. + Advanced understanding of quality standards and regulatory compliance for medical devices or diagnostics. + Strong technical ... skills in FDA , GMP, ISO 13485 compliance, process improvement, and development. + Outstanding supply chain optimization expertise and project management experience.… more
- Danaher Corporation (Brea, CA)
- …In partnership with specialist attorneys and other professionals, advise on regulatory , compliance, privacy, and litigation matters + Supervise legal professionals ... in: + Experience with healthcare regulation, including: fraud and abuse (eg, anti-kickback); FDA for medical devices; data use and privacy (eg, HIPAA, GDPR); and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …years of experience + Must be fully cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs ... activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials + Scientific knowledge/ experience in HIV prevention or… more
- Sysco (Walnut, CA)
- …other related duties as needed. + Complies with local, state and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **QUALIFICATIONS** **Education** + ... High school diploma or general education degree (GED); or equivalent combination of education and related experience. + 2 or 4-year college degree in Business Management, Supply Chain Management or similar major preferred. **Experience** + 1-3 years related… more