Director of Regulatory Compliance

6 days ago

Redwood City, California, United States Pulmonx Corporation Full time
Job Description

Pulmonx Corporation is seeking a highly experienced and skilled Regulatory Affairs Director to join our team. As a key member of our organization, you will play a critical role in ensuring the company's products meet regulatory requirements and comply with industry standards.

Key Responsibilities
  • Support Product Development and Registration:
    • Provide strategic input and technical guidance on global regulatory requirements to product development and clinical teams.
    • Evaluate risks of product and clinical safety issues during clinical phases and recommend regulatory solutions.
    • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and propose plans for changes that do not require submissions.
    • Review and assess proposals to regulatory authorities on regulatory paths and clinical plans.
    • Monitor implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
    • Provide knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships.
    • Provide regulatory guidance on strategy for proposed product claims/labeling.
    • Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
    • Manage electronic and paper registration development.
    • Ensure policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
    • Prepare cross-functional teams for interactions with regulatory authorities including panel meetings/advisory committees.
  • Support Post Approval/Post Market Activities:
    • Ensure process is in place for review and approval of advertising and promotion to ensure regulatory compliance.
    • Develop, implement, and manage systems to track required reports, supplemental submissions, and other post marketing commitments.
    • Review and approve required reports, supplemental submissions, and other post marketing commitments to maintain product registrations.
    • Review and approve change controls to determine the level of change and consequent submission requirements.
    • Develop, implement, and manage appropriate SOPs and systems to track, manage, report, and communicate product-associated event complaints, recalls, market withdrawals and vigilance reports.
    • Adapt post market strategy based on consideration of factors such as HTA, reimbursement, group purchasing pressures, state/provincial/regional restrictions, and other legislative/regulatory requirements.
  • Other Responsibilities:
    • Serve as company's deputy Person Responsible for Regulatory Compliance (PRRC).
    • Participate in Corporate initiatives as appropriate.
    • Support Quality Policy and Quality System.
    Requirements:
    • Bachelor's degree and a minimum of 12 years of experience in Regulatory Affairs in the medical device industry.
    • Demonstrated strength in regulatory submissions activities. Class III, PMA experience is strongly desired.
    • Commercial and post-market experience is required.
    • Knowledge of international regulatory requirements, EU MDR.
    • Strong project management skills and experience.
    • Proficient in timely review of technical data and clinical data.
    • Demonstrated success in fast-paced start-up, entrepreneurial work environments.
    • Ability to write clear, concise, and well thought out technical documents.
    • Strong leadership, organizational, interpersonal skills.
    • Excellent presentation skills.

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