Senior Regulatory Affairs Director, IVD & Diagnostics

Germer International; Cleveland (OH); On-site; USD 180,000 - 260,000; Full time

Job summary

Germer International in Cleveland, OH, is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategies for IVD and LDT products across the lifecycle, including pre-market submissions, post-market duties, and international documentation. The role blends strategic oversight with hands-on execution to ensure timely approvals and compliance.

You will guide FDA interactions (PMA, 510(k), amendments) and IVDR-related affairs, mentor teams, collaborate with clinical, quality,

Qualifications

• 10+ years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
• Significant experience with FDA-regulated IVD products and submissions (PMA, 510(k)).
• Strong leadership and cross-functional collaboration across clinical, quality, manufacturing.
• Excellent technical writing and regulatory documentation skills.
• Experience with international regulatory submissions and IVDR documentation is a plus.

Responsibilities

• Lead development and execution of regulatory strategies for new and existing IVD and LDT products.
• Serve as senior regulatory SME for U.S. FDA and international requirements.
• Provide strategic regulatory guidance to executives, product teams, and operations.
• Assess pathways, submission requirements, risks, and post-market obligations.
• Translate regulatory requirements into actionable development and submission plans.
• Lead interactions with outside legal, regulatory, and statistical consultants.
• Plan, prepare, review, submit, and maintain regulatory dossiers and submissions.
• Oversee IVDR Technical Documentation and international regulatory docs.
• Mentor regulatory teams and coordinate cross-functional submission efforts.

Skills

Regulatory leadership

FDA submissions (PMA/510(k))

Strategic regulatory planning

Cross-functional leadership

Technical writing

Job description

Germer International in Cleveland, OH, is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategies for IVD and LDT products across the lifecycle, including pre-market submissions, post-market duties, and international documentation. The role blends strategic oversight with hands-on execution to ensure timely approvals and compliance.

You will guide FDA interactions (PMA, 510(k), amendments) and IVDR-related affairs, mentor teams, collaborate with clinical, quality,