Senior Regulatory Affairs Specialist Jobs in Irvine, CA

Lead the charge in executing trade controls strategy for U.S.-Mexico operations, ensuring compliance with import/export regulations. Collaborate with cross-functional teams to monitor risks and drive...

Advance quality compliance by conducting audits, managing CAPAs, and enhancing systems. Collaborate with global teams to ensure regulatory readiness and continuous improvement in quality management pr...

Join a team that's dedicated to advancing clinical research through statistical expertise. Collaborate with medical professionals to design, analyze, and report on clinical studies, ensuring complianc...

Join a team that's committed to operational excellence through leadership of the Enterprise Quality Audit team, driving compliance, continuous improvement, and quality governance across business units...

Join a team that's dedicated to ensuring the quality and safety of clinical trials. As a Senior Clinical Research Associate, you'll manage site relationships, oversee monitoring activities, and contri...

Join a team that's dedicated to ensuring the highest quality and safety standards for medical devices post-commercialization. Drive compliance, process improvements, and risk management while collabor...

Transform regulatory compliance by managing medical device labeling and documentation across multiple regions, ensuring accuracy and audit readiness while collaborating with cross-functional teams to...

Lead the charge in managing complex subcontract activities, ensuring compliance with regulations and company policies while collaborating with cross-functional teams to support business objectives and...

Join our structural design team to lead innovative projects, utilizing 3D modeling software to create structural layouts and solve complex design challenges. Collaborate with multi-disciplinary teams...

Transform regulatory strategy and operations across CMC and clinical activities, leading a high-performing team to ensure compliance and successful product approvals from development through post-appr...

Drive program success in medical devices by managing projects from initiation to delivery, collaborating across functions, and ensuring customer satisfaction while adhering to compliance and quality s...

Unlock potential by leading global regulatory strategies for immunology projects, ensuring compliance and optimizing product approvals. Collaborate with cross-functional teams and regulatory agencies...

Empower healthcare innovation by providing clinical and technical support for O-Arm Imaging & Navigation products. Collaborate with surgeons and hospital staff to enhance surgical precision and improv...

Lead quality oversight for drug manufacturing, ensuring compliance with cGMPs. Collaborate with vendors on batch record review and product disposition for global clinical programs, thriving in a dynam...

Join a team that's dedicated to advancing healthcare through innovative solutions. Leverage your expertise in communication, technical writing, and regulatory knowledge to drive impactful projects in...

Lead the charge in shaping global EHS3 strategy, ensuring compliance and operational excellence across diverse functions while driving transformational initiatives and enterprise governance frameworks...

Contribute to the design and development of electronic hardware for medical devices, driving complex technical solutions and collaborating with cross-functional teams throughout the product lifecycle...

Transform the energy landscape by advising clients on regulatory strategies and market dynamics. Leverage your expertise to navigate complex compliance issues and foster relationships across the energ...

Lead the charge in ensuring quality compliance through validation, risk assessment, and cross-functional collaboration. Drive continuous improvement initiatives while supporting audits and maintaining...

Join a team that's driving innovation in medical device electronics. Lead complex designs, collaborate with cross-functional teams, and provide technical expertise throughout the hardware development...

Lead the charge in operational excellence by managing a diverse clinical team across regions, ensuring timely and quality clinical deliverables while driving strategic initiatives and fostering talent...

Elevate project success by managing permit tracking and regulatory compliance, ensuring adherence to local, state, and federal requirements while supporting incentive-related activities for optimal be...

Lead the charge in client partnerships while driving strategic growth and team development. Utilize your expertise to deliver impactful insights and solutions in a fast-paced, evolving environment, en...

Innovate global CMC regulatory strategies and submissions for biological products. Ensure high-quality compliance with US and Canadian regulations, while collaborating cross-functionally to manage lif...

Help us ensure compliance by leading cleaning validation activities and qualification processes. Collaborate with cross-functional teams to execute validation protocols and monitor GMP operations effe...