Project Manager, Regulatory Affairs / Quality Assurance

What you'd do

• 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.
• Maintain regulatory RAID and decision logs, submission trackers, correspondence logs, commitment registers, and governance materials; proactively identify risks to submission quality, completeness, timing, approvability, or regulatory compliance and facilitate mitigation plans.
• Coordinate responses to health authority questions and requests for information by establishing response teams, timelines, review and approval pathways, source-document traceability, and readiness checkpoints.
• Support regulatory intelligence and impact assessments by tracking relevant guidance, precedents, policy changes, and agency feedback, and translating potential impacts into program actions, decision requests, and schedule updates.
• Integrate Quality Assurance activities that support regulatory execution, including inspection readiness, audit and inspection commitments, corrective and preventive action (CAPA) tracking, deviation and change-control dependencies, document-control requirements, and Good Practice (GxP) compliance deliverables.
• Partner with Quality Assurance and functional leaders to coordinate inspection-readiness plans, mock inspections, evidence-room and document requests, subject-matter-expert preparation, response tracking, and remediation follow-through.

What they want

• 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.
• 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.
• Experience coordinating cross-functional teams across Regulatory Affairs, Quality Assurance, CMC, Clinical, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, and Commercial functions.
• 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.

About Intuitive Surgical · General Business

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 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. Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and…