Senior CDx/IVD Regulatory Strategist & Liaison

Merck; Carson City (NV); On-site; USD 250,000 - 350,000; Full time

Job summary

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD) to lead global regulatory strategies across the development portfolio. This role partners with R&D, Translational Medicine, Statistics, and other functions to support timely global registration and lifecycle management of diagnostic products.

The role requires strong scientific and regulatory judgment, independence in complex environments, and effective communication with

Qualifications

• Experience leading regulatory strategies for companion diagnostics (CDx) and in vitro diagnostics (IVD).
• Proven ability to provide regulatory guidance to cross-functional product teams.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic and tactical regulatory guidance to product teams and senior leaders.
• Manage regulatory activities related to development, registration, and lifecycle management of CDx/IVD products.
• Collaborate across functions and geographies to resolve regulatory issues and align on development strategies.
• Oversee or contribute to regulatory submissions (e.g., IDE, PMA, 510(k)) and interactions with authorities.

Job description

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD) to lead global regulatory strategies across the development portfolio. This role partners with R&D, Translational Medicine, Statistics, and other functions to support timely global registration and lifecycle management of diagnostic products.

The role requires strong scientific and regulatory judgment, independence in complex environments, and effective communication with