Manager, Regulatory Affairs, International - Pulmonx Corporation : Job Details

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.”

Position Overview

The Manager of International Regulatory Affairs will be responsible for overseeing all regulatory aspects of devices marketed and sold in international markets, with a specific focus on OUS, Japan, China and Korea. This position is responsible for ensuring that all products meet all regulatory requirements, assisting with international regulatory strategy, working cross-functionally and maintaining compliance with international standards.

Responsibilities and Capabilities:

• Regulatory Strategy Development: Develop and implement regulatory strategies for product registration and market entry in Japan, China, Korea, and other international markets as required.
• Submission and Approvals: Prepare and submit regulatory dossiers for product registration in international markets. Manage all aspects of the submission process to ensure timely approval of products.
• Regulatory Compliance: Monitor and ensure compliance with all international regulatory requirements and changes. Adapt strategies and processes as needed to maintain compliance.
• Cross-functional Collaboration: Work closely with R&D, Quality Assurance, and Clinical Affairs departments to gather necessary documentation and ensure regulatory strategies align with overall business objectives.
• Regulatory Input in Design: Provide expert regulatory advice during the product design and development phases, ensuring regulatory considerations are integrated into product planning from the outset.
• Data Oversight: Oversee the collection, analysis, and interpretation of clinical data to ensure it meets regulatory standards for submissions, in partnership with the Medical Affairs and Clinical teams.
• Clinical Study Compliance: Ensure clinical studies are designed and executed in compliance with regulatory requirements, and that study results are reported accurately and transparently, in partnership with the Medical Affairs and Clinical teams.
• Market Surveillance: Oversee post-market surveillance activities to ensure ongoing compliance and safety of marketed devices. Handle incident reporting and recalls in coordination with local authorities.
• Regulatory Maintenance: Manage essential post-market activities such as product registrations, renewals, and modifications. Ensure compliance with post-market surveillance requirements.
• Adverse Event Reporting: Oversee the monitoring and reporting of adverse events and product complaints to regulatory authorities in the applicable International Regions.
• Audit Preparation: Prepare and support post-market compliance audits and inspections.
• Training and Guidance: Provide regulatory guidance and training to internal teams and stakeholders on international regulatory requirements and changes.
• Stakeholder Engagement: Liaise with international regulatory authorities and bodies to facilitate processes and address queries. Build and maintain positive relationships with regulatory representatives.
• SOP Creation: Lead the development of Standard Operating Procedures (SOPs) that establish clear, compliant processes for all aspects of regulatory affairs. Ensure that SOPs are in line with the latest regulatory guidelines and corporate policies.
• Continuous Improvement: Regularly review and assess existing SOPs to identify opportunities for process improvements and efficiency gains. Implement updates to SOPs to reflect changes in regulatory requirements, technological advancements, or operational best practices.
• Quality Assurance: Collaborate with the Quality Assurance (QA) department to ensure that SOPs meet both regulatory and quality standards. Facilitate training sessions for relevant teams to ensure thorough understanding and correct implementation of revised or new SOPs.
• Cross-functional Alignment: Ensure that SOPs align with procedures from other departments that interact with regulatory processes, such as clinical affairs, product development, and manufacturing, to maintain consistency and compliance across the organization.
• Provide regular updates to the management team and lead and collate data specific to Domestic Regulatory Affairs for the organization.
• Communication: Provide regular updates to the management team and lead and collate data specific to International Regulatory Affairs for the organization.
• Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results.
• Excellent interpersonal skills.
• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.
• Other duties as assigned.

Requirements:

• Bachelor's degree in Life Sciences, Regulatory Affairs, or related field. Master's degree and RAPS-RAC preferred.
• Minimum of 8 years of experience working in a regulatory affairs role, specifically with Class II or Class III medical device experience, with a focus on International regulatory support, preferably in a management/leadership role; or 6 years of experience with related master's degree.
• Demonstrated project management skills and experience.
• Proven experience in regulatory submissions and registrations across multiple markets.
• Strong understanding of FDA and international regulatory standards, including ISO 13485 and risk management processes related to medical devices.
• Excellent organizational skills, with the ability to manage multiple projects and timelines effectively.
• Strong communication and interpersonal skills, capable of working collaboratively across cultures and geographies.
• Ability to work effectively in a fast paced and dynamic environment.
• Strong presentation skills, and strong written and verbal communication skills are required.
• Ability to write clear, concise, and well thought out technical documents.

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.

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.