![Octave](https://media.trabajo.org/img/noimg.jpg)
Head of Regulatory and Compliance
2 months ago
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.
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