- J&J Family of Companies (Santa Clara, CA)
- … regulatory submissions by analyzing data, interpreting requirements, and supporting the Regulatory Affairs team to ensure compliance with FDA, EU MDR, and ... Quality Management System policies to meet customer safety, satisfaction, and regulatory requirements. + Emphasize benchmarking and the dissemination of best… more
- Fortive Corporation (Irvine, CA)
- …administrative support to **three L1 leaders** across **Research & Development (R&D), Regulatory Affairs & Quality Assurance (RAQA), and Operations (OPS)** . ... You'll work closely with other Executive Assistants and departments across the business, bringing a proactive, solutions-oriented mindset to help leaders stay focused on business priorities while ensuring their time and resources are managed effectively. **Key… more
- Merck (South San Francisco, CA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May Be… more
- Kelly Services (Brea, CA)
- …implementation of changes. + Partner with internal teams-including design, planning, regulatory affairs , quality, and marketing-and external suppliers to ... of documentation including product labeling, instructions for use (IFUs), and regulatory submissions. + Support inventory planning to minimize obsolescence and… more
- Actalent (Sacramento, CA)
- …to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs , and Marketing. + Demonstrated ability to manage ... in design reviews to ensure product excellence and adherence to regulatory standards. Responsibilities + Develop quality assurance documentation to support new… more
- J&J Family of Companies (Irvine, CA)
- …functions including Medical Affairs , Clinical Research, Quality, R&D, and Regulatory Affairs . + Participate in workshops and projects/ initiatives to ... input and support to related functions ensuring the delivery of key regulatory and medical documents to gain and retain market access. **Job Responsibilities:**… more
- AbbVie (Irvine, CA)
- …mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/ Regulatory Affairs . Proactively identify and communicate issues impacting delivery ... customization of ICFs, patient facing materials and safety reporting. + Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment… more
- US Tech Solutions (Thousand Oaks, CA)
- …met + Serve as the primary interface with Clinical Development, Quality, and Regulatory Affairs to ensure coordination of all activities necessary to maintain ... GDEs, SOPs) need to be revised to comply with regulatory requirements or to clarify a work process +...and the team in preparing for internal, partner and regulatory audits **Top Must Have Skill Sets:** + SCPM… more
- Abbott (Temecula, CA)
- …making. + Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs , R&D, clinical, operations QA, and ensures alignment ... Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers. **Qualifications** + Bachelor's… more
- Terumo Neuro (Aliso Viejo, CA)
- …functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. ... + Manage multiple large-scale project(s) and/or multiple smaller scale projects and timelines without guidance. + Independently manage project and timelines using established project management methodology. + Communicate project status and issues in a timely,… more