Remote Chief, Clinical & Regulatory Strategy

Motif Neuro; Houston (TX); Remote; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Participation in our 401k plan

Unlimited PTO for salaried employees

Accrued PTO for hourly employees

Job summary

Motif Neuro in Houston, TX is seeking a Head of Clinical and Regulatory Affairs to lead clinical and regulatory programs for implantable neuromodulation devices. This role drives end-to-end clinical operations, trial design, budget management, and regulatory submissions with FDA involvement.

You will build a scalable clinical function in a startup environment, overseeing cross-functional teams and partnering with regulators to advance product development and patient outcomes.

Qualifications

• 12+ years of experience spanning clinical and regulatory functions in medical devices.

Responsibilities

• Oversee clinical functions and end-to-end lifecycle, focusing on Clinical Operations.
• Lead multinational industry-sponsored trials with CROs, vendors, and consultants.
• Direct study design, site strategy, patient recruitment, and data quality.
• Oversee endpoint selection, analysis plans, and data interpretation.
• Develop and execute evidence strategies spanning sponsored, partnered, and grant-funded studies.
• Manage trial timelines, budgets, and operational risk; ensure on-time, on-budget delivery.
• Lead regulatory strategy and submissions for implantable neuromodulation devices, including IDEs.
• Represent FDA interactions and post-market surveillance obligations.
• Directly manage clinical and regulatory personnel and build teams.
• Collaborate with R&D, QA, marketing, and operations to align study design.
• Engage global KOLs to guide clinical strategy.
• Travel to Houston for meetings and sites as needed.

Skills

Clinical leadership

Regulatory affairs

Cross-functional coordination

Budget management

Vendor management

KOL engagement

Strategic communication

GCP/ISO 14155

Job description

Motif Neuro in Houston, TX is seeking a Head of Clinical and Regulatory Affairs to lead clinical and regulatory programs for implantable neuromodulation devices. This role drives end-to-end clinical operations, trial design, budget management, and regulatory submissions with FDA involvement.

You will build a scalable clinical function in a startup environment, overseeing cross-functional teams and partnering with regulators to advance product development and patient outcomes.