Hiring: Director of Clinical Affairs Endoluminal Company: Intuitive Location: Sunnyvale, CA Job Posted Time: 2026-09-02 18:07:41 Target Skills & Keywords : Compliance, GCP, HBase, LESS, Make, R, SAFe About the job Experience: •30 years later, that question still fuels everything we do at Required Skills: •Primary Function of Position •The Director, Clinical Affairs- Endoluminal will guide, develop and execute long range clinical trial strategies, inclusive of first human use, regulatory studies and post-market evidence generation and provide strategic guidance and oversight for global clinical evidence strategies for Intuitive’s Endoluminal Business unit. Additionally, this role will a global vision for emerging markets and partner with representatives from other business units for process alignment. •As a key cross-functional constituent, this employee will work in a global matrix with teams across the Endoluminal Medical Officers, R&D, New and sustaining product development, Clinical Development engineering, Regulatory Affairs, Regulatory compliance, Post Market Surveillance, Global Access Value Economics (GAVE), and Global Public Affairs (GPA) to optimize clinical evidence strategies to meet business priorities. •This position will be responsible for development and coordination of various strategic and tactical clinical evidence generation activities to assist with regulatory clearance for new products and new indications •Roles And Responsibilities •Play a lead role in the development of the company’s clinical and scientific strategies, including clinical studies for new product development (first human use and/or IDE studies), post-market evidence generation or emerging markets for Intuitive’s Endoluminal technology. •Steer development and execution of clinical plans in aid of clinical trials to conform to applicable regulatory requirements (e.g. MDR, GCP or ISO 14155). •Responsible for providing strategic guidance to global clinical evidence strategy for the Endoluminal program with exceptional partnership with the business unit and GAVE representatives, including integrated evidence planning and execution for reimbursement submissions •Responsible for cross functional partnership with various key functions within the organization to shape external environment through interactions with notified body and regulatory agency and external working groups. •Highly skilled at translating strategic, corporate and technical content into clear evidence roadmap that effectively engages multiple functions. Creates key performance indicators (KPI) and Compensation: •$204,000 •$360,000 Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!