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Senior Regulatory Affairs Lead, IVD Diagnostics

Job in Cambridge, Middlesex County, Massachusetts, 02140, USA
Listing for: Precede Biosciences, Inc.
Full Time position
Listed on 2026-10-12
Job specializations:
  • Healthcare
    Healthcare Management
  • Management
    Healthcare Management
Salary/Wage Range or Industry Benchmark: 175000 - 220000 USD Yearly USD 175000.00 220000.00 YEAR
Job Description & How to Apply Below

Precede Biosciences, Inc. in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs.

This senior role owns submissions from strategy through approval and serves as the regulatory lead on cross-functional and partner teams. The role requires leading FDA interactions, coordinating US and global IVD submissions (510(k), De Novo, PMA), and guiding diagnostic development with biopharma partners.

The Senior Regulatory Affairs Lead, IVD Diagnostics role at Precede Biosciences, Inc. is now open for applications in Cambridge, MA, United States.

Learn more about the Senior Regulatory Affairs Lead, IVD Diagnostics role in the description above.

We appreciate your interest in this position.

Join Precede Biosciences, Inc. and contribute to our ongoing work.

Take a moment to read everything above and see whether this role is right for you.

Position Requirements
10+ Years work experience
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