Senior Regulatory Strategy Leader, CDx/IVD Diagnostics

Merck; Lansing (MI); On-site; USD 250,000 - 450,000; Full time

Job summary

Merck in the United States seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies for companion diagnostics and other in vitro diagnostic products within the development portfolio.

You will partner with R&D areas including Clinical Research, Biomarker Development, Translational Medicine, and Regulatory Affairs to align development plans with regulatory requirements, oversee submissions (e.g., pre-submission materials, PMA/510(k) as applicable), and guide

Qualifications

• Senior regulatory leader with deep CDx/IVD experience.
• Experience guiding global regulatory submissions.
• Ability to collaborate across diverse R&D functions.
• Strong scientific judgment and communication skills.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic regulatory guidance to development teams and senior leaders.
• Manage regulatory activities from development through lifecycle management.
• Lead regulatory submissions including IDE, PMA, 510(k) and related filings.
• Interact with regulatory authorities and external diagnostic partners.
• Ensure plans are compliant and aligned with development objectives.

Skills

Regulatory leadership

CDx/IVD knowledge

Strategic planning

Cross-functional collab

Education

Advanced degree in life sciences

Job description

Merck in the United States seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies for companion diagnostics and other in vitro diagnostic products within the development portfolio.

You will partner with R&D areas including Clinical Research, Biomarker Development, Translational Medicine, and Regulatory Affairs to align development plans with regulatory requirements, oversee submissions (e.g., pre-submission materials, PMA/510(k) as applicable), and guide