Global Executive Director, CDx/IVD Regulatory Strategy

Merck; Phoenix (AZ); On-site; USD 260,000 - 340,000; Full time

Job summary

Merck is seeking an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies for companion diagnostics and related in vitro diagnostic products. You will partner with R&D, Regulatory Affairs, Clinical, and external partners to shape development plans and filings worldwide.

The role leads a regulatory team, provides strategic oversight, assesses risk, negotiates with authorities, and ensures compliant submissions (510(k), PMA, IDE) while aligning with program

Qualifications

• Senior regulatory leadership experience in CDx/IVD products.
• Experience shaping global regulatory strategies across multiple regions.
• Proven ability to manage cross-functional teams and interact with senior leaders.

Responsibilities

• Develop and oversee global regulatory strategies for CDx/IVD products.
• Provide strategic regulatory guidance to cross-functional teams and leadership.
• Manage regulatory activities from development through lifecycle management.
• Lead regulatory interactions with authorities and external partners.
• Mentor and lead a team of regulatory professionals.
• Identify regulatory risks and develop compliant, timely mitigation strategies.
• Coordinate worldwide submissions including IDE, PMA, 510(k) as applicable.
• Collaborate across R&D, clinical development, and regulatory affairs to align plans.

Skills

Global regulatory strategy

CDx/IVD regulatory

Regulatory leadership

Stakeholder management

Job description

Merck is seeking an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies for companion diagnostics and related in vitro diagnostic products. You will partner with R&D, Regulatory Affairs, Clinical, and external partners to shape development plans and filings worldwide.

The role leads a regulatory team, provides strategic oversight, assesses risk, negotiates with authorities, and ensures compliant submissions (510(k), PMA, IDE) while aligning with program