Regulatory Affairs Lead – Medical Devices & IVD; Remote
New York, New York County, New York, 10261, USA
Listed on 2026-10-06
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Healthcare
Healthcare Compliance, Medical Science Liaison, Medical Device Industry
Location: New York
Quidel Ortho seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for new in‑vitro diagnostics and medical devices in worldwide markets. You will manage U.S. submissions, interact with FDA and global agencies, and ensure compliance with QSR, ISO, CMDR, IVDR, and CFR requirements. This role is remote eligible.
The position requires leadership, cross‑functional collaboration, and the ability to work independently on high visibility projects across regulatory disciplines.
We invite applications for the Regulatory Affairs Lead – Medical Devices & IVD (Remote) position located in New York, NY, United States.
Are you ready to take on the Regulatory Affairs Lead – Medical Devices & IVD (Remote) role at Quidel Ortho?
We would love to welcome a new Regulatory Affairs Lead – Medical Devices & IVD (Remote) to our group in New York, NY, United States.
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