Regulatory Affairs Manager Jobs in Irvine, CA

Lead our regulatory operations team in navigating UDI compliance and FDA regulations for medical devices, ensuring accurate registrations and supporting cross-functional initiatives that enhance produ...

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Lead the charge in shaping global regulatory CMC strategies for CAR T cell therapy, overseeing submissions and lifecycle management, while partnering cross-functionally to drive compliance and innovat...

Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...

Champion regulatory excellence by guiding cross-functional teams in FDA advertising compliance while mitigating risks and enhancing strategic communications to support business goals...

Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...

Empower progress at the intersection of regulatory affairs and marketing. Lead teams to navigate complex advertising strategies across therapeutic areas while ensuring compliance with industry regulat...

Lead the charge in regulatory strategy for product innovation, ensuring compliance across all markets while collaborating with cross-functional teams to enable fast-paced growth and maintain brand int...

Lead the establishment of a robust Product Quality function, enhancing governance and processes for evaluating lending products to ensure compliance, reliability, and accuracy across the financial ser...

Oversee and direct accreditation and regulatory compliance initiatives, serving as the liaison for key agencies while developing strategies to ensure adherence to standards and regulations, enhancing...

Contribute to enterprise leadership in product safety risk management, ensuring compliance and aligned processes throughout the medical imaging software product lifecycle, and leading a team of safety...

Join us to ensure quality compliance and drive continuous improvement by overseeing global quality investigations, facilitating stakeholder interactions, and implementing corrective actions based on r...

Champion regulatory compliance by supporting quality processes and product lifecycle management in the medical device sector, ensuring adherence to standards during design, development, and commercial...

Champion regulatory excellence by leading global strategies for product approvals, collaborating with cross-functional teams and external experts to ensure compliance and drive successful commercializ...

Drive compliance by supporting regulatory affairs for medical devices. Collaborate cross-functionally to manage documentation, ensure audit readiness, and maintain quality systems. This hands-on role...

Shape regulatory strategies for medical devices, leading global initiatives and cross-functional teams to ensure compliance and drive successful submissions while influencing policy at a strategic lev...

Elevate quality standards in dietary supplement manufacturing by overseeing compliance with regulatory requirements, managing QA/QC teams, and ensuring product safety through rigorous testing and insp...

Lead the charge in regulatory excellence, guiding licensing, compliance, and government relations for innovative space programs. Collaborate with cross-functional teams, shape strategies, and build a...

Drive the regulatory strategy for launch and reentry vehicles, overseeing compliance, licensing, and cross-functional collaboration. Lead a dedicated team and serve as the primary liaison with federal...

Shape regulatory compliance strategies by overseeing "Grape to Bottle" and "Bottle to Market" frameworks. Collaborate with teams to ensure accurate reporting, streamline workflows, and support interna...

Elevate your career by leading a high-performing Quality Assurance team. Ensure benefit configuration accuracy and compliance while driving process improvements across healthcare operations, promoting...

Lead the manufacturing quality function, defining processes and inspections to ensure compliance and excellence as the shop scales. Build metrology capabilities and aid in AS9100 certification, drivin...