Sr. Manager / Director, Regulatory Affairs

Pulmonx; Redwood City (CA); Hybrid; USD 175.000 - 253.000; Vollzeit

Zusammenfassung

Pulmonx is seeking a Regulatory Leader to own international registrations, EU MDR compliance, and regulatory lifecycle management for our Class II/III portfolio. This role leads registrations across the EU, Middle East, Japan and India, oversees Notified Bodies and FDA interactions, and partners with Engineering, Quality, Clinical, Marketing and Legal in a global matrix.

The ideal candidate will have 8+ years of regulatory affairs experience in medical devices and a strong track record with EU

Qualifikationen

• 8+ years of regulatory affairs experience with Class II or Class III medical devices (12+ years for Director level with 5+ years people leadership experience).
• Hands-on experience with international registrations in at least two of the EU, Middle East, Japan, and India; Director level should have led registrations across most of these markets.
• Direct experience with EU MDR technical documentation and Notified Body reviews; Director level should have led an MDR transition end to end.
• Experience with 510(k) submissions and PMA supplements; Director level should have led them and have FDA meeting experience.
• Working knowledge of EU MDR, MDCG guidance, FDA 21 CFR 807/814/820 (QMSR), ISO 13485, ISO 14971, and IMDRF guidance.

Aufgaben

• Lead international registrations in the EU, Middle East, Japan, and India, including dossiers for PMDA/MHLW, CDSCO, and SFDA, and support expansion into new markets. Support PRRC obligations under EU MDR Article 15.
• Manage in-country representatives and distributors, maintain registrations and renewals, and monitor regulatory changes for impact on products and timelines.
• Own the EU MDR transition and technical documentation and serve as primary Notified Body contact for audits, reviews, and change notifications, in partnership with Clinical and Quality.
• Review and approve advertising, promotional materials, and labeling for U.S. and international compliance, advising Marketing and Commercial on claims and substantiation.
• Represent Regulatory in audits, inspections, and CAPAs. Complete ECO's and determine reporting requirements across markets (510(k) vs. letter to file, PMA supplement, Notified Body and international notifications).
• Provide oversight for U.S. regulatory strategy and submissions, including 510(k)s, PMA supplements, annual reports, pre-submissions, and FDA correspondence
• Build strong partnerships with Engineering, Product Management, Quality, Clinical, and Commercial.

Ausbildung

Bachelor’s degree in life sciences or engineering

Advanced degree preferred for Director level

Jobbeschreibung

• Location 700 Chesapeake Drive,Redwood City, CA, 94063,United States
• Base Pay $175,000.00 - $253,000.00 / Year
• Employee Type Employee

Hybrid, 3 days per week in office

Pulmonx is a Global Leader in Interventional Pulmonology, Planning Tools, and Treatments for Obstructive Lung Disease. Based in Redwood City, California, and Neuchâtel, Switzerland, Pulmonx is the maker of the Zephyr®Valve. The Zephyr Valve was granted breakthrough status and approved by the FDA in June 2018, because according to the FDA it "represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated risks. This device offers a significant, clinically meaningful advantage over the current standard of care and therefore, its availability is also in the best interest of patients."

Overview

Pulmonx is seeking a regulatory leader to own and manage international registrations, EU MDR compliance, and regulatory lifecycle management for our Class III interventional pulmonology portfolio. This person will lead registrations across the EU, Middle East, Japan, and India, drive our EU MDR transition and ongoing compliance, and serve as the regulatory voice on advertising and promotion and engineering changes. Provide oversight on U.S. submissions (510(k), supplements and PMA). The role partners closely with Engineering, Quality, Clinical, Marketing, Legal, and Commercial teams, and works directly with Notified Bodies, FDA, and international regulators.

Responsibilities and Capabilities

• Lead international registrations in the EU, Middle East, Japan, and India, including dossiers for PMDA/MHLW, CDSCO, and SFDA, and support expansion into new markets. Support PRRC obligations under EU MDR Article 15.
• Manage in-country representatives and distributors, maintain registrations and renewals, and monitor regulatory changes for impact on products and timelines.
• Own the EU MDR transition and technical documentation and serve as primary Notified Body contact for audits, reviews, and change notifications, in partnership with Clinical and Quality.
• Review and approve advertising, promotional materials, and labeling for U.S. and international compliance, advising Marketing and Commercial on claims and substantiation.
• Represent Regulatory in audits, inspections, and CAPAs. Complete ECO's and determine reporting requirements across markets (510(k) vs. letter to file, PMA supplement, Notified Body and international notifications).
• Provide oversight for U.S. regulatory strategy and submissions, including 510(k)s, PMA supplements, annual reports, pre-submissions, and FDA correspondence
• Build strong partnerships with Engineering, Product Management, Quality, Clinical, and Commercial.

Requirements

• 8+ years of regulatory affairs experience with Class II or Class III medical devices (12+ years for Director level with 5+ years people leadership experience).
• Hands-on experience with international registrations in at least two of the EU, Middle East, Japan, and India; Director level should have led registrations across most of these markets.
• Direct experience with EU MDR technical documentation and Notified Body reviews; Director level should have led an MDR transition end to end.
• Experience with 510(k) submissions and PMA supplements; Director level should have led them and have FDA meeting experience.
• Working knowledge of EU MDR, MDCG guidance, FDA 21 CFR 807/814/820 (QMSR), ISO 13485, ISO 14971, and IMDRF guidance.
• Bachelor’s degree in life sciences or engineering required; advanced degree preferred for Director level

Preferred Qualifications

• Experience with Class III implantable or interventional pulmonary or cardiovascular devices.

Compensation

Director 217K - 253K

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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.