Senior Regulatory Strategy Lead, Surgical Systems

Intuitive; Sunnyvale (CA); Sur place; USD 212 000 - 318 000; Plein temps

Résumé du poste

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. We seek a principal-level Regulatory Affairs professional to shape strategy across surgical platforms, manage submissions, and guide lifecycle decisions in the U.S.

and international markets. The role partners with R&D, quality, and manufacturing to integrate regulatory considerations early in design, ensuring compliance for critical devices and software.

Qualifications

• Minimum 15 years of related regulatory affairs experience with a bachelor's degree; or 12 years with a master's degree; or a PhD with 8 years of experience.
• Bachelor's 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.

Responsabilités

• Lead regulatory strategy across the surgical platform, including robotic and surgical systems, instruments, accessories, disposables, and their software and digital capabilities.
• 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.
• Partner with R&D, quality, clinical, and manufacturing teams to build regulatory considerations into design, risk management, and the quality system from the outset.

Connaissances

Regulatory strategy

FDA regulations

Cross-functional collaboration

Life sciences/engineering background

Regulatory affairs expertise

Formation

Bachelor's degree in engineering, life sciences

RAC preferred

Description du poste

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. We seek a principal-level Regulatory Affairs professional to shape strategy across surgical platforms, manage submissions, and guide lifecycle decisions in the U.S.

and international markets. The role partners with R&D, quality, and manufacturing to integrate regulatory considerations early in design, ensuring compliance for critical devices and software.