Director Clinical Evaluation And Excellence (remote)

Insulet

Multiple Locations
Base: $183,225.00 - $274,837.50; bonus/equity: may...
Hybrid
Clinical research study oversight
Global regulatory submissions
Safety reporting compliance
The Director of Clinical Evaluation and Excellence will provide strategic oversight of clinical research studies globally to ensure regulatory compliance and lead global regulatory submissions and safety reporting

Job Summary

  • The Director of Clinical Evaluation and Excellence will provide strategic oversight of clinical research studies globally to ensure regulatory compliance and lead global regulatory submissions and safety reporting.
  • This position offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and employee wellness programs.
  • The role supports a culture of compliance, collaboration, and continuous improvement while managing a team of regulatory specialists, clinical writers, quality specialists, and safety professionals.

Matching Summary

The Director of Clinical Evaluation and Excellence will provide strategic oversight of clinical research studies globally to ensure regulatory compliance and lead global regulatory submissions and safety reporting.

Salary

Base: $183,225.00 - $274,837.50; Bonus/Equity: May be eligible for incentive compensation; Benefits: Medical, dental, vision insurance, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • clinical research study oversight
  • global regulatory submissions
  • safety reporting compliance
  • clinical documentation development
  • cross-functional leadership
  • ISO 14155 and EU MDR compliance
  • team management and mentoring

Nice-to-have

  • strong analytical and organizational skills
  • effective verbal and written communication
  • project management skills
  • flexible and team-oriented
  • experience with clinical documentation platforms
  • RAC certification preferred

Key Requirements

  • Bachelor’s degree in Life Sciences or related field
  • Minimum 10 years clinical research and regulatory experience
  • Proven leadership in global regulatory strategy
  • Deep knowledge of FDA, EU MDR, ISO 13485, ISO 14155, ICH GCP
  • RAC certification preferred

Work Rights

Not specified

Tailored Resume

Cover Letter