Hiring: Project Manager, Regulatory Affairs / Quality Assurance Company: Intuitive Location: Sunnyvale, CA Job Posted Time: 2026-09-16 19:27:05 Target Skills & Keywords : Regulatory Compliance About the job Experience: •30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide. •8 years of pharmaceutical or biotechnology industry experience, including substantial experience supporting Regulatory Affairs activities and at least 3 years of cross-functional program or project management responsibility. •At least 3 years of cross-functional program or project management responsibility. Required Skills: •Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. •The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life. •If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here. •Partner with Regulatory Affairs leadership to translate global and U.S. regulatory strategies into executable plans, including submission pathways, content plans, review timelines, decision points, dependencies, and resource requirements. •Develop, maintain, and communicate integrated regulatory project plans for assigned programs, covering investigational and marketing applications, amendments, annual reports, meeting requests and briefing packages, responses to health authority information requests, labeling activities, regulatory commitments, and post-approval submissions. •Drive cross-functional planning and operational execution for New Drug Application (NDA) submissions, including integrated content plans across Modules 1 through 5, document authoring and review workflows, publishing and submission-readiness milestones, critical-path management, and final filing activities. •Coordinate regulatory deliverables across Regulatory Affairs, CMC, Clinical, Nonclinical, Quality Assurance, Product Launch, and external partners, ensuring owners, due dates, dependencies, and acceptance criteria are clearly defined. •Plan and facilitate health authority interactions by coordinating meeting strategy, supporting briefing-package development, question-and-answer preparation, rehearsals, meeting logistics, minutes, commitments, and post-meeting action tracking. Qualifications: •Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs, Quality, Chemistry, Engineering, Business, or a related field, or equivalent experience. An advanced scientific or regulatory degree is preferred. •Minimum of 8 years of pharmaceutical or biotechnology industry experience, including substantial experience supporting Regulatory Affairs activities and at least 3 years of cross-functional program or project management responsibility. •Demonstrated experience supporting small-molecule development programs from clinical development through NDA submission, health authority review, approval, and launch readiness. •Strong working knowledge of U.S. Food and Drug Administration requirements, regulatory submission processes, electronic Common Technical Document (eCTD) structure, health authority interactions, labeling, regulatory commitments, and post-approval lifecycle activities. •Demonstrated ability to develop and manage integrated submission plans, content plans, regulatory timelines, review workflows, dependency maps, RAID logs, decision logs, and executive-readiness reporting. •Solid functional working knowledge of pharmaceutical Quality Assurance and GxP quality systems, including inspection readiness, audits, deviations, CAPA, change control, document control, training compliance, and quality-risk management. •Excellent communication, facilitation, and presentation skills, with the ability to synthesize complex regulatory issues, clarify decisions, and drive alignment without direct authority. •Advanced proficiency with Smartsheet and Microsoft Office, including detailed project planning, dashboards, reporting, and workflow automation. •Direct experience coordinating NDA content and submission activities across eCTD Modules 1 through 5, with particular experience integrating CMC, clinical, and nonclinical content. •Regulatory Affairs Certification (RAC), Project Management Professional (PMP) certification, or comparable credential. Compensation: •$127,900 - $216,500 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!