Director, Regulatory Affairs & Quality Assurance

Organization
Prelude Corporation
Job Location
Laguna Hills, CA 92653
Job Description

Job Summary

The candidate will be responsible for developing and executing regulatory strategy for a defined clinical plan as well as overseeing quality assurance in a clinical laboratory. The person will be responsible for ensuring compliance with state and federal regulatory requirements, clinical trials sponsor requirements and overall regulatory strategy. The candidate must have experience communicating and negotiating with regulatory agencies including success in obtaining FDA clearance(s)/approval(s). The candidate must be proficient in FDA quality system regulations, including Design Control/Risk Management and be comfortable drafting and revising regulatory and quality documentation. Experience in the laboratory and understanding of CLIA/CAP regulations is a strong plus. The ideal candidate is ambitious, quick to learn, has strong interpersonal skills, large network and is solution oriented.

 

Essential Responsibilities

  • Develop regulatory strategy and execute on the agreed upon roadmap, including leading preparation of regulatory filings
  • Serve as primary contact for regulatory agencies (FDA/CLIA/CAP/Notified Bodies)
    • Manage on-site inspections
    • Handle communication and negotiation w/ regulatory agencies
  • Oversee retrospective clinical studies and ensure compliance at clinical sites
  • Fully implement Design Control/Risk Management
  • Manage the quality system and drive quality metrics across the company
  • Harmonize CLIA quality system with QSR requirements
Requirements
  • Minimum education is a Bachelor’s degree in science, engineering or medical field; MS or MBA is preferred; PhD in relevant discipline is a plus
  • 10+ years in quality assurance/ regulatory affairs in IVD or Medical device industry
  • Demonstrated success in obtaining clearance(s)/approval(s) through 510(k), de novo 510(k) or PMA pathways for an IVD or medical device
  • Must be current with FDA and other regulatory agency policies (CAP/CLIA knowledge a strong plus but not required if otherwise highly qualified)
  • Must be comfortable communicating and negotiating with regulators
  • Excellent oral and written communication skills
  • Excellent interpersonal skills
  • High attention to detail

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