Senior Regulatory Affairs Specialist - Pulmonx Corporation

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

Other Requirements:

General:

• The person will be expected to follow and support all Company policies and procedures.
• The person must ensure their activities and those of their staff are in compliance with all legal and regulatory requirements applicable to the product lines and markets in which the Company participates.

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.