Regulatory Affairs Manager

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

Roles and 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.

Basic Qualifications

• 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.  Or years of experience.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
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