Executive Director, CDx/IVD Regulatory Strategy

Merck; Boston (MA); On-site; USD 260,000 - 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 and ensure timely registrations across development programs.

You will oversee a team of regulatory professionals, partner with R&D, Clinical, Biomarker Development, and external regulatory authorities, and shape policy and compliance for high-priority diagnostics.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic and tactical regulatory guidance to development teams and senior leaders.
• Manage regulatory activities for development, registration, and lifecycle management of CDx/IVD products.
• Provide regulatory leadership for complex programs or major components of high-priority programs.
• Assess regulatory impacts on diagnostic development, clinical development, and global registration strategies.
• Lead regulatory interactions with external diagnostic partners and regulators.
• Oversee or contribute to regulatory submissions including pre-submission materials, IDE, PMA, 510(k).
• Communicate regulatory risks and mitigation strategies to senior stakeholders across functions.

Job description

Merck is seeking an Executive Director, Regulatory Liaison for Companion Diagnostics and In Vitro Diagnostics (CDx/IVD) to lead global regulatory strategies and ensure timely registrations across development programs.

You will oversee a team of regulatory professionals, partner with R&D, Clinical, Biomarker Development, and external regulatory authorities, and shape policy and compliance for high-priority diagnostics.