Director, Regulatory Affairs

6 days ago

Redwood City, United States Pulmonx Corporation Full time

The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below.

Support Product Development & Registration:
  • Provides strategic input and technical guidance on global regulatory requirements to product development and clinical teams.
  • Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
  • Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.
  • Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.
  • Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
  • Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships.
  • Provides regulatory guidance on strategy for proposed product claims/labeling.
  • Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
  • Manages electronic and paper registration development.
  • Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
  • Prepares cross-functional teams for interactions with regulatory authorities including panel meetings/advisory committees.
Support Post approval/Post market Activities:
  • Ensures process is in place for review and approval of advertising and promotion to ensure regulatory compliance.
  • Develops, implements, and manages systems to track required reports, supplemental submissions, and other post marketing commitments.
  • Reviews and approves required reports, supplemental submissions, and other post marketing commitments to maintain product registrations.
  • Reviews and approves change controls to determine the level of change and consequent submission requirements.
  • Develops, implements, and manages appropriate SOPs and systems to track, manage, report, and communicate product-associated event complaints, recalls, market withdrawals and vigilance reports.
  • Adapts 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
  • Serves as company’s deputy Person Responsible for Regulatory Compliance (PRRC).
  • Participates in Corporate initiatives as appropriate.
  • Supports 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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