Global CDx/IVD Regulatory Strategy Leader

Merck & Co., Inc; Rockville (MD); À distance; USD 232 000 - 365 000; Plein temps

Résumé du poste

Merck & Co., Inc. seeks an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics. This senior leader shapes global regulatory strategies, guides development teams, and manages regulatory activities across multiple diagnostic programs.

You will collaborate with R&D, Regulatory Affairs, and external partners to align on requirements and timelines. The role demands strong scientific and regulatory judgment, experience with global regulatory submissions, and

Qualifications

• Significant regulatory experience in companion diagnostics and in vitro diagnostics.
• Experience developing regulatory strategies and supporting regulatory submissions for diagnostic products.
• Experience interacting with FDA or other regulatory authorities on diagnostic development and registration matters.
• Strong scientific knowledge and ability to navigate global regulatory requirements.

Responsabilités

• 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 to lifecycle management of diagnostic products.
• Provide regulatory leadership for complex programs and high-priority components.
• Assess regulatory risk and craft pragmatic, compliant strategies.
• Collaborate across geographic boundaries to resolve regulatory issues.
• Lead regulatory interactions with external diagnostic partners and authorities.
• Oversee preparation and submission of regulatory filings (IDE, PMA, 510(k), etc.).
• Communicate program risks and mitigation strategies to stakeholders.

Connaissances

Regulatory leadership

CDx/IVD regulatory

Regulatory submissions

FDA interactions

Team leadership

Strategic communication

Cross-functional collaboration

Global regulatory strategy

Formation

Bachelor's degree in biological sciences / related field

Master's degree in a relevant discipline

Doctoral degree (PhD/MD/PharmD)

Description du poste

Merck & Co., Inc. seeks an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics. This senior leader shapes global regulatory strategies, guides development teams, and manages regulatory activities across multiple diagnostic programs.

You will collaborate with R&D, Regulatory Affairs, and external partners to align on requirements and timelines. The role demands strong scientific and regulatory judgment, experience with global regulatory submissions, and