More jobs:
Senior Regulatory Affairs Lead, CDx/FDA Submissions
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-08-20
Listing for:
Foundation Medicine
Full Time
position Listed on 2026-08-20
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Foundation Medicine in Boston seeks a Senior Specialist, Regulatory Affairs (CDx) to lead regulatory submissions, shape strategy, and guide cross-functional teams through FDA pathways for companion diagnostics.
You will prepare packages, respond to agency inquiries, review validation data, and ensure compliance across regulatory activities, with emphasis on clear scientific writing and collaboration. The role also emphasizes strong communication and meticulous work.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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