- BD (Becton, Dickinson and Company) (Irvine, CA)
- **Job Description Summary** Fulfill FDA , ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to ... applicable regulatory bodies. **Job Description** We are **the makers of...Reporting (MDR) + Prepare and submit MDR reports to FDA + Identify problems and lead projects to improve… more
- Fortrex (CA)
- …procedures. + Verify compliance to all internal, customer, third-party auditing, and regulatory requirements including EEOC, OSHA, FDA , Homeland Security, EPA, ... implement and maintain Food Safety and Safety programs within multiple USDA and FDA facilities across a geographic area while effectively promoting the mission and… more
- Cordis (Santa Clara, CA)
- …quality assessments and collaborate with suppliers to improve product quality. + Support regulatory compliance by ensuring adherence to FDA and other relevant ... or equivalent combination of education and experience preferred + Expertise in the FDA and International Medical Device Quality System Regulations and ISO 13485 +… more
- Cedars-Sinai (Los Angeles, CA)
- …with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are the Primary Duties & ... concerns regarding data quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for ... study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and… more
- BeOne Medicines (Emeryville, CA)
- …GCP regulations and industry standards, in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices. ... experience with supporting and involvement in GCP inspections (main inspectorates ( FDA , EMA, CFDI etc.,)) and other country specific inspectorates (MFDS, PMDA,… more
- Cedars-Sinai (CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and Responsibilities + ... about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit… more
- Edwards Lifesciences (San Diego, CA)
- …the Specialist, Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. ... MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development… more
- Cedars-Sinai (Beverly Hills, CA)
- …with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are the Primary Duties and ... concerns regarding data quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit… more
- Cedars-Sinai (Los Angeles, CA)
- …completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact with research ... for other Clinical Research Associates. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and… more