Regulatory Affairs Manager

Intuitive•Sunnyvale, CA

About The Position

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. We’re 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. Primary Function of Position The Regulatory Affairs Manager will lead the strategy and execution of regulatory submissions for drug products, ensuring compliance with FDA and international standards. This includes chemistry, manufacturing, and controls (CMC) lifecycle, from early-stage development through post-market changes. The clinical regulatory submission and submissions, while navigating accelerated pathways

Requirements

CMC Expertise: Minimum of 8 years of experience specifically in Regulatory CMC, with a deep understanding of drug substance and drug product manufacturing.
OUS Submissions: Proven track record managing Outside the United States (OUS) submissions, particularly for the EU (EMA) and other major global markets.
State Regulatory Knowledge: Direct experience navigating US state-level regulatory requirements (e.g., wholesale distributor licenses, state manufacturing permits).
Accelerated Pathways: Hands-on experience managing products with Fast Track and/or Breakthrough Therapy designations.
Regulatory Operations: Familiarity with the technical aspects of submission management, including eCTD software and global submission standards.
Education: Bachelor’s degree in a scientific or healthcare field; advanced degree (MS, PhD, or PharmD) or Regulatory Affairs Certification (RAC) preferred.

Responsibilities

Documentation & Submission: Compile, write, and submit comprehensive dossiers (INDs, NDAs) for product approvals and licenses. Knowledge of device submissions is helpful.
Regulatory CMC: Manage CMC-specific regulatory activities, including technical review of manufacturing changes and site transfers to ensure compliance with global requirements.
Liaison & Communication: Serve as the primary point of contact for the FDA, EMA, and other health authorities; manage formal meetings and respond to high-stakes information requests.
Internal Guidance: Partner with R&D, Quality, and Marketing to provide strategic regulatory input on product development and manufacturing scale-up.
Compliance Management: Oversee internal audits, inspections, and renewals to ensure all business activities adhere to current regulations.
Regulatory Intelligence: Monitor evolving national and international laws (e.g., ICH, FDA, EU MDR) to assess impact on the current product portfolio.
Lifecycle Support: Manage post-market variations, labeling updates, and annual reports to maintain product compliance throughout its entire lifecycle.
Preparing and reviewing high-quality regulatory submissions (INDs, NDAs, PMA, 510k).
Managing Regulatory Operations, including the electronic publishing and filing of eCTD submissions.
Reviewing marketing and promotional materials for regulatory accuracy and compliance.
Developing and delivering employee training programs on regulatory compliance and new standards.
Maintaining regulatory databases and tracking systems for global product registrations.