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Head of Regulatory and Compliance

Octave Bioscience

Octave Bioscience

Legal
California, USA
Posted on Friday, May 17, 2024

Pioneering Regulatory Leader for Transformative Neuroscience Startup

Octave Bioscience is pioneering novel diagnostics, digital solutions, and data-driven analytics to revolutionize care for neurodegenerative diseases. Join our mission to advance groundbreaking products for multiple sclerosis, Parkinson's, and beyond.

The Opportunity: As Head of Regulatory and Compliance, you will architect and execute regulatory strategies related to our innovative products - from biomarker lab tests and imaging AI to mobile apps and wearables. You'll build a world-class regulatory function guiding approvals across domains like lab-developed tests, software as a medical device, and digital health tools.

What You'll Do:

  • Develop/execute regulatory strategies for Octave's pioneering platform
  • Lead regulatory submissions (FDA, international bodies) and clinical study applications
  • Own the Quality Management System, ensuring regulatory compliance
  • Serve as a regulatory expert on cross-functional project teams
  • Identify optimal approval pathways for novel products
  • Interface directly with pharma and health authorities on major filings and inspections
  • Maintain cutting-edge regulatory knowledge to influence evolving policies
  • Provide strategic regulatory guidance across the product lifecycle
  • Oversee regulatory compliance for CLIA/CAP lab operations

What You'll Need:

  • BS/MS in life sciences; regulatory certification a plus
  • 10+ years of regulatory affairs experience in LDTs, IVD, biotech, devices
  • Deep expertise in domains like diagnostics, imaging, digital health, wearables
  • Proven track record securing FDA, EMA, and global approvals
  • Extensive knowledge of GCP, QSR, 21 CFR, ISO 13485, Design Controls
  • Experience building/leading high-performing regulatory teams
  • Exceptional communicator adept at interpreting regulatory requirements
  • Self-driven problem-solver with a passion for pioneering new products

Join a Mission-Driven Team: Apply your regulatory leadership talents to deliver life-changing innovations that improve neurological care and patient outcomes. Our dedicated team thrives in a unique culture of curiosity, passion, and continuous learning as we navigate uncharted frontiers of medicine.

Octave offers an exceptional opportunity to build a pioneering regulatory function from the

ground up. We cultivate career growth with work-life balance, flexibility, and great benefits. We want to hear from you if you're an experienced regulatory leader ready to impact patients' lives.