Senior Regulatory Affairs Specialist Jobs in Irvine, CA

Advance our Space Systems initiatives by leading technical development and ensuring system integrity. Collaborate across disciplines to define requirements, validate performance, and execute cutting-e...

Accelerate progress at the forefront of manufacturing engineering, driving process improvements, equipment validation, and cross-functional collaborations to ensure reliable and compliant operations i...

Develop regulatory strategies and manage submissions for CMC, ensuring successful product delivery. Collaborate with internal teams and regulatory agencies to influence approvals and drive efficiencie...

Explore advanced imaging techniques to enhance case planning for TMTT therapies, enabling optimal procedural outcomes through collaborative analysis and training with the clinical team and healthcare...

Lead and execute quality control testing in a GMP environment, collaborating with teams to ensure compliance and continuous improvement while guiding junior staff in methodologies and practices to ele...

Join a dynamic team as a Senior Principal Engineer, leading innovative catheter solutions. Drive early-stage medical device projects to improve patient outcomes and redefine electrophysiology care thr...

Transform acquisition strategies by leveraging extensive DoD experience, guiding senior leaders, and innovating program execution for cutting-edge satellite communications systems, ensuring mission su...

Reimagine clinical contract negotiations by joining a dynamic team committed to efficiency and compliance. Support various contract types and ensure streamlined processes while interfacing with stakeh...

Take ownership of propulsion system development while leading a dynamic team. You'll drive technical excellence across phases, ensuring performance and reliability for critical space missions through...

Lead the charge in optimizing supply chains by developing effective plans and strategies to ensure production meets demand and inventory levels remain aligned with business growth while collaborating...

Unlock potential by leading propulsion system development, guiding teams through the end-to-end process for space systems. Engage in design, analysis, and test planning while mentoring colleagues and...

Elevate product quality by supporting Medical Device Quality Engineering initiatives, collaborating with R&D and cross-functional teams. Ensure compliance with regulations while driving innovative hea...

Shape the future of defense technology as a Senior Systems Engineer, bridging hardware, firmware, and cloud systems. Drive architecture, ensure coherent product integration, and own critical systems e...

Engage in the creation and coordination of Clinical Evaluation Plans and Reports, collaborating cross-functionally to ensure compliance with medical device regulations and drive innovation and quality...

Champion clinical trial success by leading site monitoring and management. Ensure high standards of patient care, compliance with protocols, and accurate data integrity through effective oversight and...

Drive compliance strategy by managing IL4/IL5 offerings, ensuring regulatory adherence across AWS-hosted environments. Collaborate with security teams, federal regulators, and technical stakeholders t...

Contribute to advanced thermal management by optimizing heat transfer in power systems, ensuring performance, safety, and reliability across multiple subsystems. Engage with teams to drive innovative...

Drive high-fidelity modeling and validation of electromechanical systems. Collaborate on risk reduction, conduct rapid turnaround studies, and support system integration efforts within a highly techni...

Engage with a dynamic CRO to oversee clinical monitoring and enhance site performance. Foster relationships, ensure compliance with regulations, and lead a team in delivering quality outcomes in clini...

Engineer innovative propulsion solutions, leading development from concept to testing. Drive system-level designs, performance analysis, and project management while mentoring teams to achieve excelle...

Shape the future of space operations by leading acquisition efforts for mission-critical projects. Leverage your expertise to drive the development and sustainment of classified space technology, ensu...

Take ownership of technical support for space acquisitions, drive system integration, and enhance efficiency through risk management and programmatic oversight in a high-stakes environment dedicated t...

Engage in shaping advanced space operations by providing expert acquisition, engineering, and technical guidance throughout the project lifecycle, supporting critical national security space capabilit...

Support critical space programs by providing expert acquisition strategies, risk mitigation, and financial management throughout the entire life cycle. Make your mark in advancing national security by...

Drive innovation in proximity sensor design for autonomous vehicles. Engage in complete lifecycle management from prototype to production, ensuring seamless vehicle integrations while collaborating ac...