- BeOne Medicines (Emeryville, CA)
- …systems configuration decisions. + Manage business processes, operations, and updates for all Regulatory systems to support internal customer needs. + ... and IT business partners to ensure effective communication and efficient management of regulatory technology and systems , as well as processes, as outlined… more
- Danaher Corporation (Brea, CA)
- …in global safety data and content authoring software solutions (ie UL WERCS Studio) and regulatory information systems . It would be a plus if you also possess ... world, more than one million tests are run on Beckman Coulter Diagnostics systems , impacting 1.2 billion patients and more than three million clinicians per year.… more
- J&J Family of Companies (Irvine, CA)
- …prototypes and production units + Collaborate with cross-functional teams (mechanical, software, systems , regulatory ) to support product development and ... and analyze electrical schematics and PCB layouts with minimal supervision + Support design, development, and testing of analog and digital electronic circuits for… more
- University of Southern California (Los Angeles, CA)
- …investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support , coordinating or ... equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation… more
- Abbott (Santa Clara, CA)
- …and approving requests for product release. + Reviews protocols and reports to support regulatory submissions. + Supports all business segment initiatives as ... comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and… more
- Medtronic (Santa Rosa, CA)
- …solutions. This role will be based in Santa Rosa, CA. The **Principal Regulatory Affairs Specialist** will support Research and Development programs with early ... maintaining a strong foundation for future software product development for the Regulatory Function and may also support broader Medtronic enterprise working… more
- Envista Holdings Corporation (Brea, CA)
- …regulatory correspondence and approvals (ex: FDA, HC, EU and ROW). + Provide regulatory support for Health Authority submissions including but not limited to ... partnership with manufacturing and RA/QA in designing and enhancing quality management systems to facilitate overall regulatory compliance. + Responsible for… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …are required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory frameworks. + Work cross functionally ... + Ability to work collaboratively in cross-functional teams. + Proficiency with regulatory databases, document control systems , and project management tools.… more
- AbbVie (Irvine, CA)
- …for the assigned medical device or device aspect of combination products. Support regulatory intelligence and policy activities in monitoring regulatory ... Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support , project management and leadership for the (Medical… more
- Abbott (Santa Clara, CA)
- …requested + Identify and present option for risk mitigation to decision makers + Support regulatory trackers for submissions to identify areas for new or ... regulatory environment. Demonstrates ability to interpret and apply regulatory requirements to software systems , including documentation, risk management,… more
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