- Abbott (Santa Clara, CA)
- …quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities + Negotiate ... and interact with regulatory authorities during the development and review ...review process to ensure submission approval + Ensure compliance with US and global product post marketing approval… more
- GRAIL (Menlo Park, CA)
- …regulatory strategy development, product validation, audits, promotional material review , on-market product support, and change control processes. This individual ... products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Review and approve labels, labeling, and promotional materials to ensure regulatory compliance . Assist in the collection of regulatory intelligence for ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
- Edwards Lifesciences (Irvine, CA)
- …also recommends multiple solutions for selection by management. Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, ... procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Prepare,… more
- Edwards Lifesciences (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support.… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Diploma/GED and 14+ years of relevant industry experience Preferred Qualifications: + Regulatory review of promotional materials for prescription drug and/or ... cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs, Advertising and Promotion. + Review of promotional, corporate, and… more
- Terumo Neuro (Aliso Viejo, CA)
- …per MicroVention procedures. + Review promotional material and labeling for regulatory compliance as assigned. + Perform and/or oversee the technical ... operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance ....written communication with regulatory agencies. + Maintain regulatory files and records. + Review change… more
- Envista Holdings Corporation (Brea, CA)
- …by relevant authorities, assess their impact on the organization, and provide timely regulatory guidance and support to ensure compliance . + Develop and maintain ... and evaluation of product, manufacturing, and labeling changes to determine regulatory reporting requirements and ensure ongoing compliance . + Follow Envista… more
- US Bank (Los Angeles, CA)
- …+ Provide legal support and guidance on enterprise-wide regulatory reporting and compliance projects. + Review and analyze regulatory issuances and ... Regulatory Group, the Law Division, Risk Management and Compliance , Audit, Finance, and Government Relations when providing legal...vary based on role, location or hours): + Healthcare ( medical , dental, vision) + Basic term and optional term… more
- Kelly Services (San Fernando, CA)
- …compliance records + Assess supplier documents and product formulations for international regulatory compliance + Maintain compliance database + Prepare ... ** Regulatory Affairs Specialist III - San Fernando, CA**...from suppliers + Maintain and update substantiation databases + Review supplier documents for compliance with AFF… more