Director of Regulatory Affairs, Imaging Agent Drug Development

Company Description

At Intuitive, we embrace the power of technology to improve lives through minimally invasive care. Our commitment to innovation has made us a leader in robotic-assisted surgery, with a diverse team dedicated to advancing global healthcare. For over 25 years, Intuitive has tackled some of the most complex challenges in the medical field, enhancing the abilities of healthcare professionals and providing better outcomes for patients. Join us in transforming the future of healthcare.

Job Title: Director of Regulatory Affairs, Imaging Agent Drug Development

Primary Function of Position

The Director of Regulatory Affairs, Imaging Agent Drug Development, plays a pivotal role at Intuitive. This position is responsible for leading significant regulatory initiatives, including New Drug Applications (NDA) for innovative small molecule fluorescence imaging agents used in conjunction with our near-infrared imaging systems. These agents significantly improve the precision of robotic surgical procedures by enhancing critical structure and cancer visualization, thereby increasing surgical efficacy and safety.

Roles and Responsibilities

• Develop and execute comprehensive regulatory strategies for US and global submissions, enhancing product development and market introductions.
• Lead cross-functional team efforts in preparing for major regulatory milestones and interactions with the Center for Drug Evaluation and Research (CDER).
• Manage and oversee all phases of regulatory submissions, from pre-market strategies to post-market compliance.
• Directly guide and support clinical, pre-clinical, and CMC operations to ensure alignment with development protocols.
• Act as the primary liaison with regulatory authorities, ensuring effective communication and collaboration throughout the regulatory process.
• Implement and optimize regulatory processes to meet the unique challenges of small molecule drug development.

Qualifications

• Advanced degree in a scientific or bioengineering field with 8-12 years in Regulatory Affairs.
• Extensive experience with NDAs, health authority interactions, and regulatory strategies in the pharmaceutical sector.
• Solid understanding of FDA regulations, GCP, and ICH guidelines.
• Exceptional communication and leadership skills, capable of navigating complex regulatory landscapes and fostering team success.
• Experience in the regulation of medical devices and knowledge of APAC and EMEA regulatory environments preferred.

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We offer a highly competitive compensation package and a work environment that supports diversity and inclusion. This role requires up to 25% travel and is based at our Sunnyvale HQ. Applicants must comply with all vaccine requirements and show proof of vaccination as per the policy of Intuitive and/or our partners.

Ready to advance the world of minimally invasive care? Apply now to join our visionary team at Intuitive.