Senior Regulatory Liaison - CDx/IVD Strategy

Merck; Rockville (MD); 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 provide senior regulatory leadership and strategic oversight across development portfolios.

You will collaborate with R&D, Clinical Research, Biomarker Development, Translational Medicine, and Regulatory Affairs to align on regulatory requirements and ensure timely global registrations of diagnostic products.

Qualifications

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic regulatory guidance to product development teams and senior leaders.
• Manage regulatory activities for development, registration, approval, and lifecycle of CDx/IVD products.
• Provide regulatory leadership for complex programs and high-priority components.
• Assess impact of regulatory requirements on development and global registration strategies.
• Review strategies to ensure scientific soundness and regulatory compliance.
• Identify regulatory risks and develop pragmatic mitigation approaches.
• Collaborate across functions and geographies to resolve regulatory issues.
• Lead regulatory interactions with external diagnostic partners and authorities.
• Oversee regulatory submissions (IDE, pre-submission materials, PMA/510(k) where applicable).
• Lead or support meetings with regulators and prepare briefing documents.
• Review labeling and manage labeling negotiations for compliant labeling.
• Partner with international colleagues to identify regulatory pathways and global development.
• Participate in regulatory due diligence and external partnerships.
• Represent the company in external regulatory engagements and policy activities.

Job description

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD) to provide senior regulatory leadership and strategic oversight across development portfolios.

You will collaborate with R&D, Clinical Research, Biomarker Development, Translational Medicine, and Regulatory Affairs to align on regulatory requirements and ensure timely global registrations of diagnostic products.