Global Regulatory Strategy Director - IVD & LDT

Socket.dev; Cleveland (OH); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Dental & Vision

Retirement plan match

Paid time off

Flexible work schedule

Job summary

Cleveland Diagnostics, Inc. is seeking a Senior Director of Regulatory Affairs to provide strategic leadership for regulatory activities across the IVD and LDT portfolio, including global strategies, pre-market submissions, and post-market obligations.

The role requires deep knowledge of FDA pathways, IVDR, and international regulations, with ability to lead cross-functional teams. You will drive submissions, maintain regulatory records, mentor staff, and partner with Quality, Manufacturing,

Qualifications

• Minimum of 10 years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
• Significant experience with FDA-regulated IVD products required.
• Demonstrated leadership experience with FDA submissions including PMAs, PMA supplements, amendments, annual reports, 510(k)s, pre-submissions, and responses to FDA questions.
• Experience with IVDR Technical Documentation, Notified Body interactions, and international regulatory submissions preferred.
• Experience leading regulatory strategy for product development, clinical validation, analytical validation, design changes, manufacturing changes, and post-market compliance.
• Strong technical writing, editing, and regulatory submission review skills.
• Ability to lead cross-functional regulatory planning and execution across multiple teams.
• Excellent communication and leadership skills.

Responsibilities

• Lead development and execution of regulatory strategies for new and existing IVD and LDT products throughout the product lifecycle.
• Oversee PMAs, PMA supplements, amendments, annual reports, 510(k)s, and international regulatory dossiers.
• Lead or support interactions with FDA, Notified Bodies, and other regulatory authorities.
• Ensure regulatory submissions are accurate, complete, scientifically sound, and submitted on time.
• Provide senior-level review of technical, clinical, analytical, manufacturing, labeling, and quality documentation.

Skills

Regulatory strategy

FDA submissions

Leadership

Technical writing

Cross-functional leadership

Regulatory compliance

Attention to detail

Document management

MS Word & Excel

Job description

Cleveland Diagnostics, Inc. is seeking a Senior Director of Regulatory Affairs to provide strategic leadership for regulatory activities across the IVD and LDT portfolio, including global strategies, pre-market submissions, and post-market obligations.

The role requires deep knowledge of FDA pathways, IVDR, and international regulations, with ability to lead cross-functional teams. You will drive submissions, maintain regulatory records, mentor staff, and partner with Quality, Manufacturing,