Senior Regulatory Liaison, CDx/IVD – Global Strategy

Merck; Trenton (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies for companion diagnostics and other in vitro diagnostic products within the development portfolio. The role partners with R&D, Clinical Research, Biomarker Development, Translational Medicine, Statistics, Regulatory Affairs, and other functions to align regulatory plans with program timelines.

You will manage a team of regulatory professionals, provide strategic guidance to senior leaders,

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic regulatory guidance to product teams and senior leaders.
• Manage regulatory activities for development, registration, and lifecycle management of CDx/IVD products.
• Lead regulatory interactions with authorities and external diagnostic partners.
• Assess regulatory risks and align strategies with program objectives and timelines.
• Collaborate across geographic boundaries to resolve regulatory issues.
• Oversee preparation and submission of regulatory filings (IDE, 510(k), PMA, etc.).
• Review labeling and negotiate regulatory requirements to ensure compliance.
• Monitor regulatory developments and contribute to policy and advocacy.
• Represent the company in external initiatives with regulators.

Job description

Merck seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies for companion diagnostics and other in vitro diagnostic products within the development portfolio. The role partners with R&D, Clinical Research, Biomarker Development, Translational Medicine, Statistics, Regulatory Affairs, and other functions to align regulatory plans with program timelines.

You will manage a team of regulatory professionals, provide strategic guidance to senior leaders,