- Abbott (Sylmar, CA)
- …and international registration assessments. What You'll Work On + Annual Reports - FDA APRs, ARCs (support), Custom Devices, Ics (support). Tracking of annual FDA ... and annual verification. + Export Documentation - CFG, COE, Notifications + UDI Support - FDA and EU + Management of EU and AU Declarations of Conformity (DoCs) +… more
- Lilly (San Diego, CA)
- …strategy development + Monitor patient safety and ensure compliance with GCP, FDA , ICH guidelines, and company policies **Cross-Functional Leadership & Influence** + ... Medical Affairs Support** + Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning + Contribute medical expertise to… more
- Abbott (Santa Clara, CA)
- …You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational ... and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. + Maintains… more
- Abbott (Alameda, CA)
- …needed. **Core Responsibilities** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and ... and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates. + Maintains… more
- Abbott (Milpitas, CA)
- …development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, coding, and ... activities under guidance and mentoring junior engineers. Adherence to FDA -compliant Design Control procedures and proficiency in software implementation are… more
- VTI Life Sciences (San Diego, CA)
- …environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP ... attendance and project coordination. + Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: + Bachelor's degree or higher in… more
- Robert Half Finance & Accounting (Oakland, CA)
- …opportunities, and driving savings while maintaining the product quality required for FDA regulatory compliance. This is a hands-on role in an organization where ... + Monitor the cost impact of design or process changes associated with FDA approval cycles or regulatory requirements. Continuous Improvement: + Evaluate the cost… more
- Abbott (San Diego, CA)
- …risk assessments and contribute to risk mitigation strategies aligned with FDA and international cybersecurity guidance. + Implementation of security risk controls ... ComplieswithU.S. FoodandDrugAdministration ( FDA )regulations,otherregulatoryrequirements, Companypolicies,operatingprocedures,processes,andtaskassignments.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …team, which is responsible for 1) the creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the ... FDA and other regulatory agencies (eg, recall letters) are...collection of information and technical writing of communications with FDA and other regulatory agencies, including periodic reports for… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …Qualifications: * Experience working with radiopharmaceuticals and knowledge of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs ... and regulatory submissions, IND filings, engagement with the FDA , IRB submissions, GCP, and CITI * Strong relationships with industry sponsors and knowledge of… more