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.

Qualifications :

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: Bachelors degree in a scientific or healthcare field; advanced degree (MS PhD or PharmD) or Regulatory Affairs Certification (RAC) preferred.  Or years of experience.

Additional Information :

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 employeeswho 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 governments 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 employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time