Description
Hybrid, 3 days per week in office
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
• RAC Certification
• Experience with Class III implantable or interventional pulmonary or cardiovascular devices.
Compensation:
Sr. Manager 175K - 204K
Director 217K - 253K
Please note that an application and resume must be completed and submitted for consideration for this opportunity.
