Position Overview

As The Sr Regulatory Affairs Specialist at Pulmonx, you will support all regulatory aspects of devices marketed and sold in US and OUS. 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 US and rest of the world
• 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.
• Excellent interpersonal skills, Focused, target driven with a positive, can-do attitude.
• Other duties as assigned.

Requirements:

• Minimum of 3-5 years of experience in regulatory affairs, specifically with Class II or Class III medical devices. 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.)