Regulatory Affairs Specialist Jobs in Los Gatos, CA

Shape compliance and governance for Molecular Lab and Project Management units, driving risk management and fostering integrity. Collaborate globally to implement innovative compliance strategies and...

Lead the charge in ensuring quality oversight, compliance, and product complaint management. Drive CAPA program effectiveness and inspection readiness while collaborating with cross-functional teams t...

Empower regulatory compliance within the 340B Program by interpreting complex regulations, advising internal teams, and ensuring operational readiness. Drive impactful educational initiatives and coll...

Manage comprehensive risk-based quality audits across multiple sites, ensuring compliance with GCP standards. Collaborate globally with cross-functional teams to enhance clinical study integrity and c...

Unlock potential by supporting project compliance tracking and permitting functions. Collaborate with agencies to ensure adherence to regulations while managing documentation and communication for con...

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 clinical trial excellence by ensuring compliance and supporting processes from start-up to close-out. Collaborate with sites to enhance patient experiences and outcomes while maintaining inspect...

Unlock potential as you drive US market access strategy, ensuring effective payer and provider engagement while leading reimbursement initiatives and enhancing patient access outcomes across the healt...

Lead the charge in defining and executing the global compliance strategy for clinical development, fostering a quality-centric culture while ensuring adherence to regulatory standards and continuous i...

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...

Take ownership of operational excellence in clinical trials by overseeing processes, guiding teams, and implementing improvements to ensure effective, compliant, and timely execution of research proto...

Transform government pricing strategies by managing client relations and ensuring accurate federal drug price calculations while mentoring a team of analysts and providing expert guidance in complianc...

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...

Engage with us to optimize legal billing processes and ensure accuracy in financial operations. This role requires collaboration across departments, managing vendor relationships, and enhancing effici...

Unlock your potential as a key leader in GxP auditing, driving compliance and quality oversight across computerized systems in regulated environments. Collaborate cross-functionally to enhance risk ma...

Drive the execution and management of clinical studies, ensuring compliance with quality standards and timelines. Collaborate with cross-functional teams while overseeing site monitoring and data inte...

Innovate and shape high-quality scientific documents that advance therapeutic candidates, managing timelines and collaborating effectively with various teams to support regulatory submissions and nonc...

Champion regulatory compliance in the APAC region by managing a team, developing strategies, and liaising with cross-functional teams to enhance Diabetes Care product portfolios and ensure adherence t...

Join a team that's dedicated to ensuring dietary supplement quality by executing robust QA GMP compliance processes. Your expertise will be pivotal in managing supplier quality and driving continuous...

Lead the charge in successful clinical trial management, ensuring compliance and alignment with regulatory standards while overseeing budgets and team performance across diverse therapeutic areas...

Transform the contract lifecycle process by drafting, negotiating, and administering agreements. Collaborate with stakeholders to ensure compliance and clarity in all contractual engagements, while su...

Unlock potential by driving technical sales in the gene therapy sphere, managing demos, and accelerating product adoption. Collaborate with Central Sales to convert opportunities and support long-term...

Join a dynamic team to develop and optimize business rule logic, ensuring alignment with operational goals. Collaborate with multiple departments to identify and resolve technical limitations, fosteri...

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 the management of quality systems, ensuring compliance and operational excellence. Collaborate across teams to enhance quality processes and drive improvements as the organi...