- Globus Medical, Inc. (San Diego, CA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project...of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Design… more
- Owens & Minor (Sacramento, CA)
- …purchase order forms and packaging slips are completed accurately. + Performs quality assurance checks on all products received before stocking or distributing ... + **Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body.** + **Current MVR...QUALIFICATIONS** **Education and/or Experience** + Knowledge of DOT and FDA regulations + Knowledge of Home Healthcare industry +… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities** + ... meetings. + Notifies direct supervisor about concerns regarding data quality and study conduct. + Works closely with a...and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research… more
- UCLA Health (Los Angeles, CA)
- …The role requires maintaining all necessary documentation in accordance with FDA regulations, Good Clinical Practice (GCP) guidelines, and the funding source. ... patient registration, data, and treatment assignment. This role will involve quality control and assurance activities related to study workflows and documentation.… more
- Merck (San Diego, CA)
- …the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with ... regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written...or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated expertise in leading regulatory filings… more
- Kelly Services (Sunnyvale, CA)
- …initial product launch (US, EU, WHO/PQ). + Authors and prepare regulatory submissions (US- FDA , IVDR, WHO/PQ) as required by project plan. + Prepares formal written ... timelines + Compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions + Critical review of… more
- Sumitomo Pharma (Sacramento, CA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop and… more
- Terumo Neuro (Aliso Viejo, CA)
- …submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral ... + Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as...Strong technical writing skills as evidence by successful US FDA Class II / III medical device submissions, EU… more
- Kelly Services (Oakland, CA)
- …is responsible for supporting the development and operations team's compliance with FDA , CLIA, CAP, IVDR, and other global regulatory requirements. This position ... . Owns and manages applicable regulatory processes and documents . Works with quality system process owners to identify and interpret applicable regulations and to… more
- Owens & Minor (El Segundo, CA)
- …purchase order forms and packaging slips are completed accurately. + Performs quality assurance checks on all products received before stocking or distributing ... + Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body. + Current MVR...warehousing and inventory management + Knowledge of DOT and FDA regulations preferred + Knowledge of Home Healthcare industry… more