Regulatory Affairs Lead k) Medical Devices; On-Site
Job in
Blue Ash, Hamilton County, Ohio, USA
Listed on 2026-08-28
Listing for:
Vein360
Full Time
position Listed on 2026-08-28
Job specializations:
-
Healthcare
Job Description & How to Apply Below
Vein
360 is seeking a Regulatory Affairs Specialist to own the 510(k) regulatory path from strategy through FDA clearance. This full-time, on-site role in Cincinnati requires hands-on experience leading 510(k) submissions and strong knowledge of U.S. regulatory expectations.
You will collaborate with design, QA, and operations to assemble complete submission packages and respond quickly to FDA questions, driving timely clearances in a lean environment.
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