Principal Regulatory Affairs

Primary Function of Position
This is a principal-level individual contributor role responsible for regulatory strategy across a complex surgical platform. This role will work across robotic and surgical systems instruments accessories disposables and the imaging sensing and connected
capabilities that support them shaping submission and lifecycle strategy from early design through post-market. Working independently and with broad discretion in setting regulatory objectives approaches and recommendations for critical assignments this role helps senior leaders connect product design intended use clinical workflow risk management and quality requirements to a robust regulatory approach in the U.S. and international markets. The role influences product and portfolio decisions represents the company in interactions with regulators and standards bodies and provides technical direction and mentoring to cross functional teams.

Essential Job Duties
Regulatory Strategy & Advisory Leadership
Lead regulatory strategy across the surgical platform including robotic and surgical systems instruments
accessories disposables and their associated software and digital capabilities.
Advise senior leaders on regulatory options for new products significant design changes and portfolio
decisions.
Lay out the regulatory risks trade-offs and recommended path for each option.
Assess the regulatory health of assigned programs by identifying risks gaps dependencies and decision
points and recommend actions that guide cross-functional priorities.
Connect intended use human factors interoperability and clinical workflow to classification submission
pathway and clinical evidence strategy.
Submissions & Lifecycle Management
Develop the submission strategy for premarket authorizations across pathways (510(k) De Novo PMA HDE)
and their international equivalents.
Guide preparation of premarket submissions and lead substantive interactions with regulatory agencies.
Lead regulatory strategy for clinical investigations including IDEs and related study submissions.
Advise on international clinical investigation requirements that support evidence generation and market access.
Guide post-market regulatory activities such as recalls field actions adverse event reporting and inspection
and audit responses

Standards Quality & Cross-Functional Partnership
Partner with R&D quality clinical and manufacturing teams to build regulatory considerations into design risk
management and the quality system from the outset.
Apply and help shape relevant consensus standards (ISO IEC AAMI and other FDA-recognized standards) in
design and submission strategy.
Mentor regulatory and cross-functional colleagues and provide technical guidance without direct management
responsibility.
Agency Engagement & External Representation
Represent the company with regulatory agencies notified bodies standards organizations and industry
groups.
Support regulatory strategies for international market access.
Track regulatory developments and emerging expectations including those affecting surgical system software
connected and data-enabled features and translate them into practical guidance for the business

Qualifications :

Required Experience and Education
Minimum 15 years of related regulatory affairs experience with a bachelors degree; or 12 years with a masters degree;
or a PhD with 8 years of experience; or an equivalent combination of education and experience.
Bachelors degree in engineering life sciences or a related technical discipline required; PhD preferred.
Regulatory Affairs Certification (RAC) preferred.
Experience with international standards development standards interpretation or the use of consensus standards in
regulatory submissions preferred.
Required Knowledge Skills and Abilities
Deep expertise in regulatory strategy for complex medical device systems including surgical platforms instruments
accessories disposables and associated software or digital features.
Knowledge of the regulatory considerations for software digital health cybersecurity data-enabled features and AI/ML-
enabled functionality.
Strong command of FDA and international medical device regulatory requirements submission pathways and quality
system regulations (e.g. 21 CFR 820 ISO 13485).
Working knowledge of the consensus standards relevant to surgical and complex medical devices (ISO IEC AAMI) and
how to apply them in design and submissions.
Track record of representing a company with regulatory agencies standards bodies or industry groups.
Track record of working with and influencing across functions (R&D clinical quality product and business leadership).

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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

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