Director, Regulatory Affairs - Pulmonx Corporation

Pulmonx is looking for an experienced Director of Regulatory Affairs to join our dynamic Regulatory Affairs team! This position is a hybrid role and will require some onsite time at our offices in Redwood City, CA.

Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: https://www.youtube.com/@zephyr-by-pulmonx

Responsibilities and Capabilities:

• Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies that align with company goals and ensure compliance with all regulatory requirements across various regions, including but not limited to the US, EU, and Asia.
• Team Leadership: Manage and mentor a team of Regulatory Affairs professionals, fostering a culture of high performance and continuous improvement. Oversee recruitment, training, and professional development activities within the team.
• Submission and Approvals: Lead efforts in preparing and submitting regulatory filings, such as 510(k), PMA, and international submissions, ensuring timely approvals for new products and any product modifications. Monitor regulatory procedures to ensure all products continuously meet quality, safety, and efficacy standards.
• Stakeholder Engagement: Act as the primary regulatory liaison with external regulatory bodies, including the FDA, and other international entities. Build and maintain strong relationships with these agencies to facilitate negotiations and address regulatory issues effectively.
• 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 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.
• 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.
• Provide regular updates to the management team and lead and collate data specific to Domestic Regulatory Affairs for the organization.
• Executive Collaboration: Regularly update and advise the executive leadership team on regulatory strategies, project status, and potential regulatory risks on company operations and strategy.
• Manages 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:

• Requires Minimum of 12 years of progressive’ experience working in a regulatory affairs role, specifically with Class II or Class III medical device experience, with previous management/leadership experience with a Bachelor’s degree in a Life Sciences, Regulatory Affairs, or related field; or 10 years experience with an advanced degree (MS or PhD).
• Regulatory Affairs Certification (RAC) is preferred.
• Strong leadership and team management skills, with a track record of building and leading effective teams. Excellent mentoring and coaching abilities.
• 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.
• Strong problem-solving and organizational skills and the ability to manage multiple projects effectively under tight deadlines.
• Strong communication and excellent interpersonal skills, capable of working collaboratively across cultures and geographies.
• Ability to work effectively in a fast paced and dynamic environment.
• Strong presentation, written and verbal communication skills required.
• Ability to write clear, concise, and well thought out technical documents.
• Computer skills: MS Word, PowerPoint, Adobe Acrobat Professional, Excel.

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.

Compensation: $200,000 - $240,000/year DOE

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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