Global CDx/IVD Regulatory Lead & Strategy

Merck & Co.

Rahway (NJ)

Remote

USD 232,000 - 365,000

Full time

2 days ago

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Job summary

Merck & Co., Rahway, NJ, seeks an Executive Director, Regulatory Liaison for CDx/IVD to lead global regulatory strategies across companion diagnostics and IVD products. You will partner with R&D, Regulatory Affairs, and external authorities to shape development plans, oversee submissions, and guide a multidisciplinary team through complex regulatory challenges in a fast-moving portfolio.

The role requires strategic vision, regulatory acumen, and the ability to communicate with senior leaders

Qualifications

Significant regulatory experience in companion diagnostics and/or in vitro diagnostics.
Experience interacting with the U.S. FDA or other regulatory authorities on diagnostic development and registration matters.
Strong scientific knowledge and leadership in regulatory programs and submissions.

Responsibilities

Develop and oversee global regulatory strategies for CDx/IVD products.
Provide regulatory guidance to product teams and senior leaders.
Manage regulatory activities from development through lifecycle management, including submissions.
Lead regulatory interactions with external diagnostic partners and regulators.
Oversee preparation and approval of submissions such as IDEs, PMAs, 510(k)s, and global filings.
Monitor regulatory developments and advocate for policy in CDx/IVD.