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Head of Clinical and Regulatory Affairs

Motif Neurotech · Houston, Texas, United States · On-site

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About Motif Neurotech

Motif Neurotech is a company that develops minimally invasive bioelectronic implants for monitoring and treating severe mental illnesses. Backed by KdT Ventures.

About the role

We are seeking candidates with experience leading multi-site clinical trials for implantable neuromodulation devices to join our team as Head of Clinical and Regulatory Affairs .

What they're looking for

  • 12+ years of experience spanning clinical and regulatory functions at a medical device company specialized in active implantables, with at least 4 years focus in neuromodulation or implantable BCI devices
  • 6+ years of experience partnering with cross-functional teams on study design that supports product development and approval strategy
  • 6+ years of experience managing clinical trial budgets, resources, timelines, and risk, with a track record of on-time, in-budget delivery
  • 5+ years of experience directly managing clinical and/or regulatory teams
  • Demonstrated experience leading a multi-function clinical department
  • Demonstrated experience leading regulatory strategy and submissions for implantable neuromodulation devices, including direct interaction with the FDA (pre-submission meetings, IDE submissions, etc.)
More about this role

Motif is a medical device startup based in Houston, Texas. We are designing and developing minimally invasive electronic solutions for serious mental health conditions. Powered by our patent-pending methods for wireless power and data transmission, our goal is to create the smallest implantable brain stimulator to treat people with mental health disorders.

We are an early-stage startup with funding from venture capital firms, grants, and private angel and founder investments.

Motif’s technology stack consists of a small implant that is wirelessly powered via magnetic fields from an external wearable transmitter, configured and controlled from a programming interface. It delivers novel stimulation therapy to cortical targets and will evolve to record biomarkers of symptoms, disease state, and therapy response.

We are currently completing the development of our first minimally invasive neural stimulation system and preparing for future versions with additional functionality based on our platform technology.

We are seeking candidates with experience leading multi-site clinical trials for implantable neuromodulation devices to join our team as Head of Clinical and Regulatory Affairs...

Read the full posting on Motif Neurotech's site ↗

Clinical

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