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Senior Director Regulatory Affairs

Company: Eargo
Location: San Jose
Posted on: February 17, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • Provide leadership and expertise in the maintenance of the existing quality system (includes 21 CFR 820 compliance)
  • Support continuous improvement programs, including scalability of existing systems
  • Host and lead all external audits with FDA, FDB, etc.-- Respond to all corrective actions in a timely manner and drive all issues to closure.--
  • Be the main point of contact for the day-to-day oversight of the operations at the CM in areas of Quality system compliance--
  • Prepare regulatory plans/strategies for new and modified products in US/Europe/Asian countries
  • Review product labeling, advertising, and promotional materials as required for conformance with applicable regulations
  • Gather information, provide detailed reporting and provide management with key updates, including Management Review.
    • BS in Electrical Engineering, Mechanical Engineering or related engineering fields--
    • 8 - 10+ years of progressive and demonstrably successful regulatory experience leading to successful regulatory clearance/approvals and product launches
    • 5-8 years of experience in medical device quality engineering or other equivalent regulated environments
    • Must have a practical and working knowledge of ISO 13485, 21 CFR 820
    • Demonstrated experience in technical project/program leadership and process management
    • Demonstrated ability to communicate and work collaboratively across functions, such as engineering and product groups
    • Lean and/or Six Sigma experience a plus

Keywords: Eargo, San Jose , Senior Director Regulatory Affairs, Executive , San Jose, California

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