Principal Regulatory Affairs Specialist

Overview

As Principal Regulatory Affairs Specialist at Pulmonx, you will play a critical role within the regulatory affairs function, driving the full spectrum of regulatory activities, from initial market authorization through post-market compliance, for our US and international device portfolio. You will collaborate closely with RA colleagues, contributing to critical decisions on registration strategy and market access while serving as a go-to regulatory resource for cross-functional teams.

Day-to-day, you will own regulatory change processes and ensure our quality systems keep pace with evolving standards and regulations. Your work will be visible and meaningful, directly shaping how we navigate FDA and international requirements, maintain our licenses and certifications, and ultimately get life-changing devices to the patients who need them. We are looking for someone who brings regulatory expertise, a commitment to excellence, and genuine collaborative spirit to thrive in our team-oriented environment.

• Manage the regulatory strategy and registration pathway for assigned products and markets, ensuring timely market authorization and sustained compliance across the US and international portfolio. Drive strategic decisions on regulatory submission types, timelines, and risk mitigation strategies in alignment with business objectives.
• Lead and mentor regulatory affairs team members and cross-functional partners in execution of registration and compliance activities, developing internal knowledge base through guidance on complex regulatory assessments, submission strategy, and standards interpretation.
• Serve as a key regulatory voice, providing meaningful advice to cross-functional teams and senior leadership on market access strategy, regulatory risks, and compliance implications of business decisions.

• Maintain regulatory registration tracking to monitor license status, expiration dates, and global compliance obligations; author regulatory documentation (CERs, PMCF, PSUR, periodic updates, PMS, annual reports) in alignment with US and international requirements.
• Support regulatory operations for US and international markets, helping to manage the full lifecycle of registrations, licenses, approvals, and certifications, including 510(k) submissions, IDE supplements, license renewals, periodic updates, reportable changes, and other submissions required to maintain market access.

• Own change control activities within Master Control, including initiating, reviewing, and approving changes that impact regulatory submissions, post-market reporting, labeling, or licenses; conduct regulatory impact assessments to determine submission requirements and notification strategies across markets.
• Coordinate cross-functional implementation of approved regulatory changes, including labeling updates, IFU revisions, and risk mitigations, ensuring timely and consistent execution globally.

• Ensure RA processes are documented, controlled, and auditable within the quality system; develop and maintain RA procedures, work instructions, and templates within the controlled document management system.
• Monitor regulatory guidance and standards relevant to the product portfolio; conduct gap assessments against updated requirements (FDA guidance, MDR/MDCG documents, IMDRF guidance, ISO/IEC standards) and recommend remediation strategies.

• Collaborate with Marketing, Quality Assurance, Legal, R&D, and Production to align on regulatory strategy and integrate regulatory requirements into product development and commercialization; communicate regulatory changes and risk-based recommendations to stakeholders and management with clarity and business impact focus.
• Demonstrate strong interpersonal and presentation skills with a focused, results-oriented mindset, proactive problem-solving approach, and commitment to fostering collaborative, positive working relationships across functional teams.

• Lead meetings and communications with regulatory authorities (FDA, EU notified bodies, international regulators) to advocate for products and address compliance questions; maintain complete records of all submissions, approvals, and regulatory communications to support audit readiness.

• 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 technical reports, business correspondence and standard operating procedures.
• Proven communication skills. Experience presenting clearly and persuasi... to technical, non-technical, and regulator audiences.
• Extensive knowledge of a broad set of regulations, standards and…