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Remote Regulatory Affairs Lead CDx & IVD Submissions

Remote / Online - Candidates ideally in
Marlborough, Middlesex County, Massachusetts, 01752, USA
Listing for: Quest Diagnostics Incorporated
Remote/Work from Home position
Listed on 2026-10-20
Job specializations:
  • Science
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 120000 - 150000 USD Yearly USD 120000.00 150000.00 YEAR
Job Description & How to Apply Below
Position: Remote Regulatory Affairs Lead for CDx & IVD Submissions

Quest Diagnostics Incorporated is seeking a Regulatory Affairs Manager for global regulatory submissions, including CDx programs, PMAs, 510(k) s and IDEs. This remote role collaborates with cross-functional teams to drive regulatory strategy and market growth.

The role requires a Bachelor's degree with 4+ years in regulatory submissions for IVDs, plus experience with IHC assays and oncology CDx projects is a plus. RAC is preferred; US/EU regulatory exposure is beneficial.

Step into the Remote Regulatory Affairs Lead for CDx & IVD Submissions role at Quest Diagnostics Incorporated in Marlborough, MA, United States and grow with us.

We would love to welcome a new Remote Regulatory Affairs Lead for CDx & IVD Submissions to our group in Marlborough, MA, United States.

For the Remote Regulatory Affairs Lead for CDx & IVD Submissions position at Quest Diagnostics Incorporated, we are reviewing applications now.

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