Senior Regulatory Affairs Specialist Jobs in Santa Clara, CA

Transform supplier quality through rigorous audits and partnerships, ensuring top-notch materials and services meet industry and regulatory standards while driving continuous improvement in the new pr...

Contribute to regulatory excellence by coordinating U.S. submissions, ensuring compliance with FDA standards, and maintaining vital documentation for the Obesity Therapeutic Area, while collaborating...

Shape the future of regulatory compliance by leading advertising and promotion strategies. Guide cross-functional teams in navigating FDA regulations while mentoring junior professionals and ensuring...

Join a team that's shaping regulatory strategy in a complex surgical platform. Engage with cross-functional teams to connect product design, clinical workflow, and quality standards, while representin...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Drive the global regulatory CMC strategy and execution for cell and gene therapies, ensuring compliance and effective submissions throughout all development phases. Collaborate cross-functionally to g...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Unlock potential by shaping global regulatory strategies for cell therapies, guiding complex programs from development through approval, and driving stakeholder engagement to enhance patient access an...

Champion the validation of cutting-edge lab instrumentation while collaborating with diverse teams to ensure customer readiness and operational excellence. Your expertise will drive quality and compli...

Transform your career with a Senior Product Safety Engineer role. Utilize your expertise in standards such as IEC 62368-1 and IEC 61010-1, support diverse projects, engage with clients, and guide juni...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Unlock potential by leading regulatory strategies for innovative medical devices. Collaborate with teams to ensure compliance, execute FDA submissions, manage project timelines, and establish processe...

Champion the future of regulatory strategy, driving operational excellence and cross-functional alignment for drug candidates, ensuring timely execution from INDs to approvals while mitigating risks a...

Unlock your potential in clinical safety by reviewing and assessing adverse events in cardiovascular trials. Collaborate with cross-functional teams to ensure compliance and accurate reporting while c...

Champion quality assurance excellence to ensure compliance in life sciences. Collaborate across teams while overseeing GxP activities and maintaining data integrity throughout the product lifecycle in...

Drive impactful medical communication strategies by crafting precise scientific content and collaborating with cross-functional teams to meet diverse client needs within a dynamic healthcare landscape...

Join a strategic leadership role that executes regulatory strategies globally, overseeing complex submissions and driving cross-functional collaboration to ensure successful market access and complian...

Engage as a key quality engineering leader, driving compliance and continuous improvement in medical device manufacturing, focusing on NPI and risk management to enhance product reliability and lifecy...

Optimize product quality and compliance in manufacturing by implementing robust risk management practices, ensuring adherence to regulatory standards, and driving continuous improvement initiatives th...

Transform regulatory frameworks for advanced medical devices, guiding teams through compliance and submission processes. Leverage expertise in FDA regulations while fostering cross-functional collabor...

Lead the charge in quality assurance as a clinical and technical expert, driving compliance, assessing device performance, and collaborating cross-functionally to enhance product quality and ensure pa...