Principal Regulatory Affairs

About the job

Job Description

Primary Function of Position This is a principal-level individual contributor role responsible for regulatory strategy across a complex surgical platform. This role will work across robotic and surgical systems, instruments, accessories, disposables, and the imaging, sensing, and connected capabilities that support them, shaping submission and lifecycle strategy from early design through post-market. Working independently and with broad discretion in setting regulatory objectives, approaches, and recommendations for critical assignments, this role helps senior leaders connect product design, intended use, clinical workflow, risk management, and quality requirements to a robust regulatory approach in the U.S. and international markets. The role influences product and portfolio decisions, represents the company in interactions with regulators and standards bodies, and provides technical direction and mentoring to cross functional teams.

Essential Job Duties Regulatory Strategy & Advisory Leadership • Lead regulatory strategy across the surgical platform, including robotic and surgical systems, instruments, accessories, disposables, and their associated software and digital capabilities. • Advise senior leaders on regulatory options for new products, significant design changes, and portfolio decisions. • Lay out the regulatory risks, trade-offs, and recommended path for each option. • Assess the regulatory health of assigned programs by identifying risks, gaps, dependencies, and decision points, and recommend actions that guide cross-functional priorities. • Connect intended use, human factors, interoperability, and clinical workflow to classification, submission pathway, and clinical evidence strategy. Submissions & Lifecycle Management • Develop the submission strategy for premarket authorizations across pathways (510(k), De Novo, PMA, HDE) and their international equivalents. • Guide preparation of premarket submissions and lead substantive interactions with regulatory agencies. • Lead regulatory strategy for clinical investigations, including IDEs and related study submissions. • Advise on international clinical investigation requirements that support evidence generation and market access. • Guide post-market regulatory activities such as recalls, field actions, adverse event reporting, and inspection and audit responses

Standards, Quality & Cross-Functional Partnership • Partner with R&D, quality, clinical, and manufacturing teams to build regulatory considerations into design, risk management, and the quality system from the outset. • Apply and help shape relevant consensus standards (ISO, IEC, AAMI, and other FDA-recognized standards) in design and submission strategy. • Mentor regulatory and cross-functional colleagues and provide technical guidance, without direct management responsibility. Agency Engagement & External Representation • Represent the company with regulatory agencies, notified bodies, standards organizations, and industry groups. • Support regulatory strategies for international market access. • Track regulatory developments and emerging expectations, including those affecting surgical system, software, connected, and data-enabled features, and translate them into practical guidance for the business