Global Regulatory Leader, Surgical Robotics & AI

PROCEPT BioRobotics K.K.; San Jose (CA); Presencial; USD 320.000 - 520.000; Jornada completa

Descripción de la vacante

PROCEPT BioRobotics is seeking a world-class Regulatory Executive to serve as Vice President of Global Regulatory Affairs. This leader will craft and drive a forward-looking regulatory strategy for PROCEPT's surgical robotics portfolio, including oncology indications such as prostate cancer, across multiple global jurisdictions.

The role entails driving submissions, regulatory intelligence, and post-market compliance, with strong emphasis on onboarding and integrating new technologies, and

Formación

• VP-level regulatory experience or higher in medical devices.
• Excellent writing skills for regulatory documentation.
• Robust knowledge of clinical, hardware, and software components.
• Experience with AI/ML functionality regulatory submissions, oncology-focused submissions, and PMA-level submissions in surgical robotics.

Responsabilidades

• Develop, refine, and maintain an agile global regulatory infrastructure and regulatory intelligence to address evolving market and compliance demands.
• Oversee robust US and global regulatory strategies (FDA 510(k), PMA, IDE, EU MDR) that align with PROCEPT BioRobotics' portfolio, including oncology indications.
• Provide expert guidance on strategic, operational, and budgetary planning to optimize regulatory pathways and timelines for new technologies and oncology-related device submissions.
• Work closely with R&D, Quality, Legal, Marketing, Manufacturing, Operations, and Clinical teams to synchronize product development and global regulatory submissions.

Conocimientos

Regulatory leadership

FDA submissions

PMA strategy

Cross-functional collaboration

AI/ML regulatory

Descripción del empleo

PROCEPT BioRobotics is seeking a world-class Regulatory Executive to serve as Vice President of Global Regulatory Affairs. This leader will craft and drive a forward-looking regulatory strategy for PROCEPT's surgical robotics portfolio, including oncology indications such as prostate cancer, across multiple global jurisdictions.

The role entails driving submissions, regulatory intelligence, and post-market compliance, with strong emphasis on onboarding and integrating new technologies, and