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.