Director Regulatory Affairs - Cardiac

Company Description

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.

Job Description

Primary Function of Position

This role will support our global Cardiac Surgery Program. This role is a Director-level Regulatory Affairs leader, who will work with business unit leaders, clinical teams, reimbursement teams to define and execute global cardiac regulatory strategy, leads a cross-functional team leveraging regional teams and programs, ensures competitive market access, and represents the organization in senior regulatory and industry external facing activities.

Essential Job Duties

• Establish global regulatory strategy and drive execution for cardiac surgery products.
• Oversee worldwide regulatory submissions and approvals, market entry readiness, and related negotiations with regulatory aauthorities and external stakeholders.
• Collaborate with cross-functional teams to develop global clinical evidence strategies, including HEOR, to accelerate market access.
• Lead end-to-end regulatory due diligence for M&A and partnerships, identifying regulatory risks and compliance gaps to support investment and integration.
• Develop departmental budgets, resource forecasting, and succession planning.
• Mentor senior managers; drive talent pipeline initiatives.
• Communicate regulatory strategy and risk to executive leadership to drive alignment and decisions..
• Guide integration of new regulations, guidance, policy, standards into product and business strategies.
• Oversee regulatory input for mergers, acquisitions, and global expansion.
• Demonstrated experience leading regulatory authorizations and driving commercialization strategies for cardiovascular devices across the U.S., EU, and APAC.

Qualifications

Required Experience and Education

• Minimum 12 years of global regulatory affairs leadership and bachelor's degree in STEM, or equivalent combination of education and experience, e.g., relevant PhD with 5+, or relevant MS with 8+
• Have an experience, successfully bringing a Class III device to market by PMA in the US and under EU MDR class III requirements

Required Knowledge, Skills and Abilities

• Expertise in global regulatory strategy, agency negotiation, and industry representation.
• Director-level leadership, policy, and risk management skills.
• Mastery of regulatory requirements (FDA, EU MDR, ISO 13485, etc.).
• Talent development, program execution, and change leadership.
• Strategic and persuasive communication ability.

Preferred Knowledge, Skills and Abilities

• Advanced degree in STEM, Regulatory Affairs, or Business
• RAPS-RAC Medical Devices

Physical Requirements

• Not applicable

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 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…