Global Regulatory & Clinical Strategy Director

Meditrial; New York (NY); On-site; USD 180,000 - 320,000; Full time

Job summary

Meditrial seeks a strategic leader to head Regulatory & Clinical Affairs, reporting to the Chief Medical Officer. You will develop global regulatory and clinical strategies for medical device and pharma approvals, leveraging a deep regulatory network and experience with FDA and Notified Bodies.

The role collaborates across functions to ensure compliant trials and submissions. The position emphasizes leadership, cross-functional guidance, and building high-performing teams within a fast-paced

Qualifications

• Bachelor's degree in Life science; Master’s degree a plus.
• 10+ years in Regulatory Affairs in medical devices; 10-15 years in clinical research.
• Experience leading teams and interacting with FDA, Notified Bodies, and KOLs.

Responsibilities

• Develop and execute global regulatory and clinical strategies for approvals.
• Lead regulatory submissions and ensure clear documentation of clinical results.
• Collaborate with FDA, Notified Bodies, and investors; engage KOLs.

Skills

Leadership

Regulatory affairs

Clinical research

GxP knowledge

FDA interactions

Strategic direction

Communication

Education

Bachelor's degree in Life science

Master's degree in scientific/health field

Job description

Meditrial seeks a strategic leader to head Regulatory & Clinical Affairs, reporting to the Chief Medical Officer. You will develop global regulatory and clinical strategies for medical device and pharma approvals, leveraging a deep regulatory network and experience with FDA and Notified Bodies.

The role collaborates across functions to ensure compliant trials and submissions. The position emphasizes leadership, cross-functional guidance, and building high-performing teams within a fast-paced