Principal Regulatory Affairs Specialist

Redwood City, CA

Hybrid

The standard work arrangement for this role is hybrid, with an expectation of working onsite at Pulmonx’s Redwood City, California facility at least three days per week. Pulmonx may consider a U.S.-based remote arrangement for an exceptionally qualified candidate whose experience closely aligns with the role. Remote candidates should expect periodic travel to Redwood City for team meetings, planning, and other business needs.

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. A primary aspect of the role is ownership of Regulatory Affairs activities for global adverse-event reportability assessments and timely submission and follow-up of required regulatory reports, in routine partnership with the QA Complaint Management team.

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.
• Serve as the primary RA owner for global regulatory reportability assessments arising from complaints, adverse events, clinical events, product malfunctions, and other post-market information; document clear, defensible reporting decisions in accordance with applicable procedures and market-specific requirements. Prepare, submit, track and follow through closure required initial, supplemental/interim, and final reports for Pulmonx’s global product portfolio, including U.S. Medical Device Reports (MDRs), EU vigilance reports, and adverse-event reports for Japan and other OUS markets, including through authorized representatives, license holders, or in-country partners, as applicable.
• 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.)

Compensation: $145,000 - $175,000 (SF Bay Area)

$130,000 - $165,000 (non-SF Bay Area)

Please note that an application and resume must be completed and submitted for consideration for this opportunity.

Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.