Senior CDx/IVD Regulatory Strategy Lead

Merck; Pierre (SD); On-site; USD 210,000 - 275,000; Full time

Job summary

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead regulatory strategies across companion diagnostics and in vitro diagnostic products. The role partners with R&D, Translational Medicine, and Regulatory Affairs to align on development and global registration plans.

The position requires strategic leadership, the ability to communicate with senior leaders, and experience guiding regulatory submissions and lifecycle management across global programs.

Qualifications

Responsibilities

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products.
• Provide strategic CDx/IVD regulatory guidance to product development teams and senior leaders.
• Manage regulatory activities from development through lifecycle management of CDx/IVD products.
• Provide regulatory leadership for complex programs and high-priority components.
• Identify regulatory risks and develop pragmatic mitigation strategies.
• Collaborate across geographic boundaries to resolve regulatory issues.
• Lead regulatory interactions with external diagnostic partners and regulatory authorities.
• Oversee preparation and review of regulatory submissions (e.g., 510(k), PMA, IDE) and related materials.
• Represent the company in external regulatory activities and policy discussions.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

CDx/IVD regulatory

Regulatory submissions

Stakeholder management

Communication to senior leaders

Tools

eCTD

Regulatory systems

Job description

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead regulatory strategies across companion diagnostics and in vitro diagnostic products. The role partners with R&D, Translational Medicine, and Regulatory Affairs to align on development and global registration plans.

The position requires strategic leadership, the ability to communicate with senior leaders, and experience guiding regulatory submissions and lifecycle management across global programs.