Senior Regulatory Affairs Specialist - da Vinci SinglePort

Job Description Primary Function of Position 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. The Senior RA Specialist works across the organization and liaises with global regulatory counterparts on a wide range of products including capital equipment, instruments and accessories (single use or re-usable), and software, focusing on supporting ongoing changes and continuous improvement to these products. Essential Job Duties Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation Evaluate changes to products including changes to design, material, labeling, packaging, manufacturing process, and facility Assess the impact of the product/process changes and determine regulatory pathway for US markets Present regulatory strategy and status in internal group settings Gather information from international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals Prepare internal documentation, and prepare and submit regulatory filings including non-filing justifications (NFJ) and 510(k)s Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization) as required Perform other duties as required #J-18808-Ljbffr Intuitive