Senior Regulatory Strategy Director – IVD & LDT

Cleveland Diagnostics; Cleveland (OH); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Employer-paid medical

Dental & Vision for family

Retirement plan 4% match

Generous PTO & holidays

Flexible work schedule

Job summary

Cleveland Diagnostics seeks a Senior Director of Regulatory Affairs to lead regulatory strategy for its IVD and LDT portfolio, ensuring compliant global submissions and ongoing regulatory obligations. The role interacts with executive leadership and cross-functional teams to drive timely approvals and lifecycle management.

You will guide regulatory planning, oversee submissions, and mentor regulatory staff, while maintaining high standards of documentation, risk management, and compliance in a

Qualifications

• Minimum 10 years in regulatory affairs within medical devices, diagnostics, or IVD.
• Experience with FDA submissions (PMA, 510(k), etc.).
• Experience leading cross-functional regulatory programs and teams.

Responsibilities

• Lead development and execution of regulatory strategies across the product lifecycle for IVD and LDT products.
• Oversee premarket submissions and post-market obligations, including international documentation.
• Provide executive regulatory guidance to leadership and cross-functional teams, and manage regulatory risks.

Skills

Regulatory leadership

FDA submissions

IVD expertise

Cross-functional collaboration

Job description

Cleveland Diagnostics seeks a Senior Director of Regulatory Affairs to lead regulatory strategy for its IVD and LDT portfolio, ensuring compliant global submissions and ongoing regulatory obligations. The role interacts with executive leadership and cross-functional teams to drive timely approvals and lifecycle management.

You will guide regulatory planning, oversee submissions, and mentor regulatory staff, while maintaining high standards of documentation, risk management, and compliance in a