Senior Regulatory Affairs Specialist - da Vinci SinglePort

The Senior Regulatory Affairs Specialist serves as the primary point of contact for regulatory strategy and execution of projects involving complex electromechanical, software-controlled robotic systems, instruments and accessories, SaMD, and advanced imaging systems. This role is integral to Intuitive, a global leader in robotic-assisted surgery and minimally invasive care, known for technologies like the da Vinci surgical system and Ion. The specialist collaborates across the organization and with global regulatory counterparts to support ongoing changes and continuous improvement of these products.

Key responsibilities include supporting product engineering and manufacturing teams on regulatory issues, reviewing design input, risk management, and test documentation. The specialist evaluates changes to products, including design, material, labeling, packaging, manufacturing processes, and facilities, assessing their impact and determining regulatory pathways for U.S. markets. Additionally, they present regulatory strategies and statuses in internal group settings, coordinate global regulatory submissions and approvals, and oversee third-party agency testing as required.

The ideal candidate possesses a minimum of 8 years of experience in a medical device company, focusing on regulatory submissions and technical documentation. A Bachelor's degree or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy is preferred. Essential skills include a working understanding of FDA regulations, the ability to work with cross-functional project teams, strong verbal and written communication skills, and proficiency in reviewing and providing critical feedback on design documentation. Strong interpersonal and project management skills are also crucial.

Compensation for this role varies by region. In Region 1, the salary ranges from $151,700 to $218,300 annually, while in Region 2, it ranges from $128,900 to $185,600 annually. The position follows a set schedule with weekly onsite work, the percentage of which is defined by the leader. Intuitive offers a collaborative and innovative work environment, emphasizing creativity, rigor, and teamwork to make surgery smarter, safer, and more human. Employees are united by a purpose to improve patient outcomes worldwide, contributing to meaningful work that has the potential to change lives.