Principal Regulatory Affairs Specialist

Overview Company Overview Pulmonx is a global leader in interventional pulmonology, providing minimally invasive technologies, planning tools, and evidence-based treatments for people living with severe emphysema and advanced chronic obstructive pulmonary disease (COPD), a progressive lung condition characterized by severe breathing difficulty that can significantly restrict daily activities and negatively impact quality of life. Position Overview The Principal Regulatory Affairs Specialist drives the full spectrum of regulatory activities, from initial market authorization through post-market compliance, for Pulmonx's US and international device portfolio. This highly visible role shapes FDA and international regulatory strategy, owns change management processes, and serves as a trusted regulatory resource for cross-functional teams and senior leadership. Key Responsibilities Define and lead regulatory strategy for assigned products and markets across the Pulmonx portfolio; drive submission type selection, timeline planning, and risk mitigation decisions aligned to business and clinical objectives. Manage the full lifecycle of domestic and international registrations across multiple products simultaneously, including Q-Subs, PMA modules/supplements, 510(k)s, IDEs, license renewals, and reportable changes; maintain global registration tracking for license status, expiration dates, and compliance obligations across all markets. Author, review, and submit regulatory filings to FDA CDRH, EU Notified Body and global regulatory agencies; serve as primary contact during interactive review cycles, lead Pre-Sub meetings, manage deficiency responses, and maintain complete records of all regulatory authority interactions. Lead and mentor RA team members and cross-functional partners on regulatory assessments, submission strategy, and interpretation of applicable regulations and standards (QMSR, EU MDR 2017/745, MDCG, IMDRF, ISO 13485, ISO 14971); serve as the primary regulatory voice to senior leadership on market access strategy, compliance risk, and business decision implications. Support U.S. post-market reporting (PMA annual reports, 30-day notices, MDRs), labeling compliance, and license maintenance; support EU MDR post-market documentation (CERs, PMCF, PSURs, PMS plans, Technical Documentation); and conduct regulatory impact assessments for changes across U.S., EU, and global markets. Support the change control process by assessing regulatory significance, approving change orders, and driving execution of resulting registration updates or submissions globally. Monitor evolving FDA, MDR/MDCG, IMDRF, and ISO/IEC requirements; proactively identify compliance gaps, recommend remediation strategies, and ensure all RA processes are documented and audit-ready. Collaborate with Commercial, Marketing, QA, Legal, R&D, and Operations to integrate regulatory requirements into product development, design changes, and commercialization. General Requirements Minimum of 7 years of experience in regulatory affairs, specifically with Class II or Class III medical devices. Bachelor’s degree or equivalent experience. Experience authoring submissions, technical reports, business correspondence and standard operating procedures. Proven communication skills. Experience presenting clearly and persuasively, catering responses to technical, non-technical, and regulator audiences. Demonstrated working knowledge of a broad set of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.). Other Requirements The person will be expected to follow and support all Company policies and procedures. The person must ensure their activities and those of their staff are in compliance with all legal and regulatory requirements applicable to the product lines and markets in which the Company participates. Join a mission-driven organization improving outcomes for patients with advanced lung disease. You will work on a differentiated, globally distributed portfolio of innovative devices, digital health solutions, and emerging technologies, all within a collaborative team committed to your professional growth. #J-18808-Ljbffr Pulmonx