Head of Clinical and Regulatory Affairs
New
M
Motif NeurotechMedical Device Startup
Remote (Houston, Texas preferred)Full-TimeManager
Salary not disclosed
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Job Details
- Experience
- 12+ years of experience spanning clinical and regulatory functions at a medical device company
- Required Skills
- GCP
Requirements
- 12+ years of experience spanning clinical and regulatory functions at a medical device company specialized in active implantables.
- 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.
- 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.
- Direct, hands-on ownership of a multi-site clinical trial from site activation through study close-out.
- Working knowledge of GCP, ISO 14155, and applicable device regulatory requirements.
- A track record of representing an organization at clinical sites, clinical meetings, and similar venues.
Responsibilities
- Oversee all clinical functions and own the clinical lifecycle end-to-end, with an immediate focus on Clinical Operations.
- Oversee and lead execution of multi-national industry-sponsored clinical trials in partnership with CROs, specialized vendors, and consultants.
- Manage study design, site strategy, patient recruitment, and data quality to ensure regulatory and product performance goals are met.
- Lead regulatory strategy and execution, including IDE and other submissions for future products.
- Represent Motif directly with FDA and other regulatory bodies, including pre-submission meetings.
- Directly manage clinical and regulatory personnel, including hiring, onboarding, training, and performance management.
- Partner with cross-functional teams to ensure study design supports product development and market access strategy.
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