Director Regulatory Affairs - Cardiac

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.

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

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
start 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 candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s 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.