Principal Regulatory Affairs Specialist

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.”

Workplace type: Hybrid (Remote will be considered for candidates in the Western US)

Position Overview

As the Principal Regulatory Affairs Specialist at Pulmonx, you will support all regulatory aspects of devices marketed and sold in international markets, with a specific focus on OUS, Japan, China, and Korea. Your expertise will be crucial in ensuring that all products meet regulatory requirements and in assisting with the development of international regulatory strategies.

Responsibilities and Capabilities:

• Manage all regulatory activities related to the registration and compliance of medical devices in international markets, particularly in OUS, Japan, China, and Korea.
• Ensure that all products comply with relevant regulations and standards throughout the product lifecycle. Develop and implement international regulatory strategies to facilitate market entry and product approvals.
• Collaborate cross-functionally with teams in Commercial, Marketing, Quality Assurance, and Legal to ensure alignment on regulatory matters. Monitor and analyze changes in international regulations and assess their impact on existing and future products.
• Prepare and submit regulatory documentation to regulatory authorities in target markets.
• Lead and participate in meetings with regulatory authorities, as needed, to advocate for Pulmonx products and clarify regulatory positions.
• Maintain accurate records and documentation of regulatory submissions and communications with regulatory bodies. Stay current with industry trends and best practices in international regulatory affairs.
• Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results.
• Excellent interpersonal skills, Focused, target driven with a positive, can-do attitude.
• Other duties as assigned.

Requirements:

• Minimum of 8+ years of experience in regulatory affairs, specifically with Class II or Class III medical devices, focusing on international regulatory support. Experience in a management or leadership role is preferred. Bachelor’s degree in a Life Science is required.
• Experience authoring technical reports, business correspondence and standard operating procedures
• Proven communication skills. Experience presenting clearly and persuasively to technical, non-technical, and regulator audiences
• Extensive 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.)

Preferred Qualifications

• RAC Certification

Compensation: $137,500 - $159,500/annually, depending on experience

When joining Pulmonx, you are part of an organization that attracts and hires the best talent on the planet! You will be working with a great team of dedicated, friendly and collaborative individuals, developing novel and game changing product(s). We are dedicated to the development and growth of our colleagues.

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.