Director/Sr. Director Regulatory Affairs

Company: Pulmonx Corporation
Location: San Jose
Posted on: November 13, 2024

Job Description:

Director/Sr. Director Regulatory AffairsPulmonx is looking for an experienced Director/Sr. Director of Regulatory Affairs to join our dynamic Regulatory Affairs team!* Will consider Sr. Director level depending upon experience.Workplace type: Hybrid (Remote will be considered for candidates in the western US)Responsibilities and Capabilities:

• Create, lead and manage 510(k), PMA, and IDE submissions in US and submissions in OUS, ensuring timely completion and compliance with applicable regulations.
• Provide strategic regulatory guidance to cross-functional teams (e.g., R&D, clinical, operations, legal, marketing) to ensure regulatory requirements are met throughout the product lifecycle.
• Act as the main point of contact for regulatory authorities, managing all communication, including pre-submissions, Q-subs, and meetings with regulatory bodies.
• Ensure timely preparation and submission of post-market reports, supplements, and required regulatory filings to maintain compliance.
• Evaluate and provide guidance on product claims, labeling, advertising, and promotion to ensure compliance with FDA and global regulations.
• Collaborate with clinical teams on regulatory submissions and trial designs, ensuring compliance with regulatory requirements for clinical trials.
• Evaluate preclinical, clinical, and manufacturing changes, determining regulatory impact and submission requirements.
• Provide regulatory intelligence, keeping teams updated on changes to global standards and regulations. Assess and communicate changes which impact our products.
• Prepare cross-functional teams for interactions with regulatory authorities, including advisory committees and panel meetings.
• Develop and implement regulatory policies and processes to streamline submission processes and improve compliance oversight.
• Manage relationships with external regulatory consultants, vendors, and notified bodies to facilitate submission processes and certifications.
• Present regulatory risks, strategies, and potential product impacts to senior leadership, providing insight into business and regulatory decision-making.
• Train and mentor internal teams on regulatory compliance, keeping leadership updated on any regulatory changes affecting product development or market access.Requirements:
  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field (Advanced degree preferred).
  • RAC Certification.
  • Minimum of 12 years of regulatory affairs experience in the medical device industry, with demonstrated success in managing 510(k), PMA, and IDE submissions.
  • Proven ability to present complex regulatory strategies and risks to senior leadership and executive teams.
  • Strong understanding of FDA, EU MDR, and global medical device regulations, with experience in regulatory strategy development.
  • Experience managing post market activities for commercialized products.
  • Demonstrated strength in regulatory submissions activities. PMA experience is strongly desired.
  • Knowledge of international regulatory requirements is strongly desired.
  • Strong project management skills and experience.
  • Excellent communication and leadership skills, with the ability to lead cross-functional teams.Compensation: $200,000 - $240,000/year DOE (will consider the Sr. Director level for the right candidate).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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Keywords: Pulmonx Corporation, Tracy , Director/Sr. Director Regulatory Affairs, Executive , San Jose, California