Executive Director, CDx/IVD Regulatory Strategy

Merck; Helena (MT); On-site; USD 180,000 - 280,000; Full time

Job summary

Merck seeks an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD). This senior regulatory leader will develop and oversee global regulatory strategies to support the company’s diagnostic development portfolio and global registrations.

You will partner with Research and Development colleagues across Clinical Research, Biomarker Development, Translational Medicine, Statistics and Regulatory Affairs, plus external diagnostic partners and authorities,

Qualifications

• Extensive experience leading regulatory strategy for CDx/IVD products.
• Strong cross-functional collaboration across R&D and regulatory authorities.
• Proven track record in medical device regulatory submissions and lifecycle management.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic regulatory guidance to product development teams and senior leadership.
• Lead regulatory activities related to development, registration, approval, and lifecycle management of CDx/IVD products.
• Provide regulatory leadership for complex programs or major components of high-priority programs.
• Assess regulatory impact on development, clinical programs, and global registration strategies.
• Review and approve regulatory submissions, communications, and labeling as applicable.

Job description

Merck seeks an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD). This senior regulatory leader will develop and oversee global regulatory strategies to support the company’s diagnostic development portfolio and global registrations.

You will partner with Research and Development colleagues across Clinical Research, Biomarker Development, Translational Medicine, Statistics and Regulatory Affairs, plus external diagnostic partners and authorities,