Vice President, Quality and Regulatory Affairs

Omniscient Neurotechnology (o8t); United States; Remote; USD 205,000 - 220,000; Full time

Benefits offered by this job

100% health insurance

Fully remote work

Job summary

Omniscient Neurotechnology is seeking a Vice President, Clinical Affairs to lead our clinical function as we grow into new indications and markets. This hands-on executive role will own the clinical and regulatory evidence strategy, lead submissions, and serve as the clinical voice in product strategy.

Remote work across the US and internationally, reporting to the COO. You will build the clinical plan supporting product development and commercialization, define evidence strategies for each

Qualifications

• 10+ years in clinical affairs or regulatory for medical devices.
• Direct FDA submissions experience (510(k) or De Novo) and Pre-Submission meetings.
• Familiar with GCP, ISO 14155, ISO 14971, 21 CFR Parts 50, 56, and 812; EU MDR knowledge.
• Bachelor's degree in life sciences, biomedical engineering, physics, or related field.
• MD/PhD/MSc in neuroscience or related field.
• Experience with SaMD, neuroimaging, or AI/ML-based devices.
• Familiarity with neurosurgery, neurology, or psychiatry workflows.

Responsibilities

• Build and run the clinical plan that supports product development, research, and commercialization
• Define the evidence strategy for each product and indication, including U.S. pathway selection (510(k), De Novo, PMA) and international sequencing (Health Canada, EU MDR, TGA)
• Lead clinical sections of regulatory submissions, plan and run FDA Pre-Sub meetings, and turn agency feedback into smart study designs
• Own CEPs, CERs, and post-market clinical follow-up, plus real-world evidence programs that support new indications and label expansions
• Oversee study start-up compliance, from risk and IDE determinations to IRB approvals and informed consent
• Partner with Quality, Regulatory, R&D, Product, and Market Access to bring clinical insight into everything we build
• Stay ahead of evolving rules for AI-enabled and software medical devices, like FDA PCCPs and the EU AI Act
• Represent Omniscient with key opinion leaders, clinical partners, and industry forums, and support publications and presentations
• Mentor and grow our clinical and research team

Skills

Clinical leadership

Regulatory submissions

GCP & ISO knowledge

Team leadership

Medical devices

Education

MD/PhD/MSc neuroscience

Bachelor's in life sciences/biomedical engineering/physics

Job description

Omniscient Neurotechnology | Remote [US ] | Full-time

Help shape how the world understands the brain.

At Omniscient, we build FDA-cleared software that maps the human brain’s networks, giving neurosurgeons and clinicians insight they’ve never had before. We’re a small, fully remote team of about 56 people across the US, Canada, and Australia, and we’re looking for a Vice President, Clinical Affairs to lead our clinical function as we grow into new indications and markets.

This is a hands‑on executive role. You’ll own our clinical and regulatory evidence strategy, lead the clinical content of our submissions, and be the clinical voice in our biggest product and strategy decisions. You’ll report to our Chief Operating Officer.

What you’ll do

• Build and run the clinical plan that supports product development, research, and commercialization
• Define the evidence strategy for each product and indication, including U.S. pathway selection (510(k), De Novo, PMA) and international sequencing (Health Canada, EU MDR, TGA)
• Lead clinical sections of regulatory submissions, plan and run FDA Pre-Sub meetings, and turn agency feedback into smart study designs
• Own CEPs, CERs, and post‑market clinical follow‑up, plus real‑world evidence programs that support new indications and label expansions
• Oversee study start‑up compliance, from risk and IDE determinations to IRB approvals and informed consent
• Partner with Quality, Regulatory, R&D, Product, and Market Access to bring clinical insight into everything we build
• Stay ahead of evolving rules for AI‑enabled and software medical devices, like FDA PCCPs and the EU AI Act
• Represent Omniscient with key opinion leaders, clinical partners, and industry forums, and support publications and presentations
• Mentor and grow our clinical and research team

What you bring

• 10+ years in clinical affairs, QA, or regulatory affairs for medical devices, including people leadership
• Direct, hands‑on responsibility for FDA submissions (510(k) and/or De Novo) and Pre‑Submission meetings
• Working knowledge of GCP, ISO 14155, ISO 14971, 21 CFR Parts 50, 56, and 812, and EU MDR
• A bachelor’s degree in life sciences, biomedical engineering, physics, or a related field
• The ability to translate complex clinical and regulatory requirements into practical, workable plans
• An MD, PhD, or MSc in neuroscience or a related field
• Experience with SaMD, neuroimaging, or AI/ML‑based devices, including designing clinical validation studies
• Familiarity with neurosurgery, neurology, or psychiatry clinical workflows

Why Omniscient

• Work that directly improves patient outcomes in brain surgery and care
• A seat at the leadership table at a company small enough that your impact is visible every day
• Fully remote, with colleagues across three countries
• Compensation range: $205,000-220,000
• Great Benefits, including 100% paid employee health insurance coverage