Senior Regulatory Affairs Specialist at Pulmonx Corporation in Redwood City, CA

Company Overview

Pulmonx is a Global Leader in Interventional Pulmonology, Planning Tools, and Treatments for Obstructive Lung Disease. Based in Redwood City, California, and Neuchtel, 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."

Position Overview

The Senior Regulatory Affairs Specialist will play a critical role in ensuring that the company's medical devices comply with global regulations, focusing on managing submissions, audits, and postmarket obligations. This position requires strong regulatory knowledge, an ability to manage technical documentation, and expertise in regulatory compliance. The Senior Regulatory Affairs Specialist will collaborate across teams to manage complaint reporting, support audits, and ensure compliance with EU MDR and other applicable regulatory standards.

Responsibilities and Capabilities:

Oversee the regulatory aspects of complaint handling, ensuring compliance with internal processes and external regulatory requirements.
Assess and determine the reportability of complaints and adverse events to regulatory authorities, ensuring timely submission.
Provide regulatory support during internal and external audits, working closely with notified bodies and ensuring all documentation is in order.
Conduct assessments for product changes, clinical data, and documentation to confirm compliance with relevant regulations.
Ensure compliance with EU MDR by preparing and maintaining up-to-date technical documentation.
Manage the creation, maintenance, and updates of technical files to ensure product compliance with regulatory bodies.
Liaise with the (BSI, FDA and other agencies) and other notified bodies for certifications, registrations and ensuring alignment with regulatory standards.
Handle the process of acquiring and maintaining regulatory certifications, ensuring submissions are made in a timely manner for renewals and new product approvals.
Oversee regulatory-related fees and manage contracts with vendors related to submissions and certifications.

Requirements:

Bachelor's degree in science, Engineering, or a related field. Understanding of ISO13485, ISO14971, FDA Complaint Management and reportability requirements, EU Vigilance reporting
Experience managing technical files, registrations and certifications
Minimum of 5 years of regulatory affairs, quality assurance experience in the medical device industry.
Strong project management skills and experience with technical documentation.
Knowledge of EU MDR, FDA, and other global regulatory requirements.
Excellent communication, leadership, and organizational skills.
Proficient in MS Word, PowerPoint, Excel, and regulatory submission tools

Compensation: $105,000 - $145,000 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.

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