Chief Clinical & Regulatory Affairs Leader

Motif Neurotech; Houston (TX); On-site; USD 180,000 - 270,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k plan

Unlimited PTO

Job summary

Motif Neurotech is seeking a Head of Clinical and Regulatory Affairs to oversee the clinical department and end-to-end trials for implantable neuromodulation devices. The role partners with Leadership, Quality, R&D, Operations, and Marketing to advance regulatory milestones and evidence generation.

The position is remote (Houston, TX preferred) with travel as needed to headquarters, clinical sites, and industry events.

Qualifications

• 12+ years of experience spanning clinical and regulatory functions at a medical device company specialized in active implantables.
• Experience leading multi-site clinical trials for implantable neuromodulation devices.

Responsibilities

• Oversee clinical functions and lifecycle end-to-end, focusing on Clinical Operations, trials, and field engineers.
• Lead regulatory strategy and submissions, including IDE and interactions with FDA and other bodies.
• Build and scale clinical and regulatory teams; manage CROs, vendors, and consultants for sponsored trials.

Skills

Clinical leadership

Regulatory affairs

Trial management

Cross-functional collaboration

FDA interactions

Budget management

KOL engagement

GCP/ISO 14155 knowledge

Job description

Motif Neurotech is seeking a Head of Clinical and Regulatory Affairs to oversee the clinical department and end-to-end trials for implantable neuromodulation devices. The role partners with Leadership, Quality, R&D, Operations, and Marketing to advance regulatory milestones and evidence generation.

The position is remote (Houston, TX preferred) with travel as needed to headquarters, clinical sites, and industry events.