Director, Clinical Affairs & Regulatory Strategy

Noctrix Health, Inc.; Pleasanton, Northern (CA, KY); Hybrid; USD 240,000 - 280,000; Full time

Job summary

Noctrix Health, Inc. is seeking a strategic Director of Clinical Affairs to lead planning, execution, and oversight of clinical studies for our drug-free wearable therapy.

You will drive evidence generation to support regulatory submissions, reimbursement, and commercialization while ensuring quality, safety, and on‑time delivery. This role partners with Regulatory Affairs, Quality, Product Development, and external vendors to scale our clinical programs.

Qualifications

• 8+ years in clinical affairs or clinical research within medical devices.
• Experience leading Clinical Affairs personnel, CROs, and vendors.
• Proven oversight of device clinical programs from start-up to close-out.

Responsibilities

• Plan, execute, and oversee medical device clinical studies end-to-end.
• Develop strategies supporting regulatory submissions, reimbursement, and commercialization.
• Provide sponsor oversight of trials, manage sites, budgets, and timelines.
• Ensure compliance with FDA, GCP, ISO 14155 and company procedures.
• Lead cross-functional collaboration across Clinical Research, Regulatory, Quality, and Product Development.

Skills

Leadership

Clinical Affairs expertise

Project management

Communication

Education

Bachelor’s degree in Nursing, Life Sciences, Biomedical Engineering, or related

Master’s degree (preferred)

Job description

Noctrix Health, Inc. is seeking a strategic Director of Clinical Affairs to lead planning, execution, and oversight of clinical studies for our drug-free wearable therapy.

You will drive evidence generation to support regulatory submissions, reimbursement, and commercialization while ensuring quality, safety, and on‑time delivery. This role partners with Regulatory Affairs, Quality, Product Development, and external vendors to scale our clinical programs.